Drugs / Sacituzumab Tirumotecan
Sacituzumab Tirumotecan
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed female breast nipple and areola cancer 1 milestone | |||||
| Filed | China (NMPA) | 佳泰莱® | female breast nipple and areola cancer | 2025-05-22 | “the Application is the fourth indication application for sac-TMT that has been accepted by the NMPA” kelun-biotech.com ↗ |
| Filed lung cancer 2 milestones | |||||
| Filed | China (NMPA) | — | lung cancer | 2024-10-31 | “The Application is the third NDA for sac-TMT that has been accepted by the NMPA.” kelun-biotech.com ↗ |
| Filed | China (NMPA) | — | lung cancer | 2024-08-20 | “The Application is the second NDA for sac-TMT that has been accepted by the NMPA.” kelun-biotech.com ↗ |
| Filed triple-negative breast carcinoma 2 milestones | |||||
| Filed | China (NMPA) | 佳泰莱® | triple-negative breast carcinoma | 2026-07-30 | “sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®) has been accepted for review” kluspharma.com ↗ |
| Filed | China (NMPA) | — | triple-negative breast carcinoma | 2024-03-19 | “an NDA for sac-TMT in patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of...” kluspharma.com ↗ “the sNDA for sac-TMT for second-line and above treatment of HR+/HER2- BC was accepted by the Center for Drug Evaluation of the National Medical Products Administration” kelun-biotech.com ↗ “SKB264's NDA filing for TNBC backline treatment has been accepted by the State Drug Administration” kelun-biotech.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | China (NMPA) | — | first-line PD-L1-positive non-small cell lung cancer | 2026-05-21 | “A new indication application for sac-TMT in combination with pembrolizumab (KEYTRUDA ® ) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 TPS≥1%...” kelun-biotech.com ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07702305 | Jun 2026 → Dec 2027 expected | neoplastic meningitis | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06049212 | Oct 2023 → Dec 2027 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1/211 trials | ||||||
| Phase 1/2 | NCT07586943 | Jun 2026 → Dec 2029 expected | cancer | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07286149 | Apr 2026 → Aug 2029 expected | lung cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07139470 | Aug 2025 → Apr 2027 expected | triple-negative breast carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06780111 | Jul 2025 → Jan 2032 expected | esophageal squamous cell carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06637423 | Dec 2024 → Mar 2029 expected | non-invasive bladder urothelial carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06469944 | Sep 2024 → Sep 2029 expected | esophageal cancer, gastroesophageal adenocarcinoma, gastroesophageal junction adenocarcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06445972 | Aug 2024 → May 2028 expected | esophageal cancer, gastroesophageal adenocarcinoma, gastroesophageal junction adenocarcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06483334 | Jul 2024 → Mar 2028 expected | urothelial carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06428409 | Jun 2024 → Oct 2029 expected | biliary tract cancer, colorectal cancer, pancreatic ductal adenocarcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05319730 | May 2023 → Jun 2027 expected | esophageal squamous cell carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04152499 | Feb 2020 → Nov 2025 overdue | breast cancer, cervical cancer, endometrial carcinoma, gastric adenocarcinoma +6 | Klus Pharma Inc. | Active not recruiting | No outcome recorded |
| Phase 266 trials · 1 met primary | ||||||
| Phase 2 | NCT07815197 | Jan 2027 → Mar 2028 expected | squamous cell carcinoma of penis | Latin American Cooperative Oncology Group | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07804966 | Jan 2027 → Mar 2030 expected | vaginal squamous cell carcinoma, vulvar squamous cell carcinoma | Latin American Cooperative Oncology Group | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07521670 | Nov 2026 → Oct 2028 expected | salivary gland adenoid cystic carcinoma, thyroid gland papillary carcinoma | National Cancer Centre, Singapore | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07854509 | Oct 2026 → Dec 2027 expected | non-small cell lung carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07785609 | Oct 2026 → Sep 2031 expected | cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT07819578 | Oct 2026 → Dec 2028 expected | non-small cell lung carcinoma | Shaodong Hong | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07823270 | Oct 2026 → Dec 2028 expected | esophageal squamous cell carcinoma | Hebei Medical University Fourth Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07850791 | Oct 2026 → Oct 2028 expected | biliary tract cancer | Haitao Zhao, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT07511023 | Sep 2026 → Mar 2031 expected | squamous cell carcinoma | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07718854 | Sep 2026 → Sep 2036 expected | ovarian clear cell adenocarcinoma | Tufts Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07639086 | Aug 2026 → Mar 2030 expected | prostate cancer, prostate neuroendocrine neoplasm | Virginia Commonwealth University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07701681 | Aug 2026 → Sep 2028 expected | esophageal squamous cell carcinoma, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07697586 | Aug 2026 → Aug 2028 expected | non-small cell lung carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07689292 | Jul 2026 → Aug 2027 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07811752 | Jul 2026 → Dec 2027 expected | esophageal squamous cell carcinoma | Shanghai Chest Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07662863 | Jul 2026 → Dec 2028 expected | peripheral neuropathy, urinary bladder cancer, urothelial carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07686588 | Jul 2026 → Dec 2027 expected | head and neck carcinoma | Biying Chen | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07701122 | Jul 2026 → Jul 2027 expected | biliary tract cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07324629 | Jun 2026 → Apr 2028 expected | thymic carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06706219 | May 2026 → Nov 2028 expected | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07343479 | May 2026 → Jun 2027 expected | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Zhejiang Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07579598 | May → Dec 2026 expected | salivary gland adenoid cystic carcinoma | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07458113 | May 2026 → May 2028 expected | triple-negative breast carcinoma | Yale University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07438626 | Apr 2026 → Jun 2028 expected | SMARCB1-deficient kidney medullary carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07545213 | Apr 2026 → Feb 2028 expected | non-small cell lung carcinoma | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07501169 | Apr 2026 → Aug 2027 expected | small cell lung carcinoma | Sichuan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07561463 | Apr 2026 → Jan 2027 expected | pancreatic ductal adenocarcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07670013 | Apr 2026 → Jan 2028 expected | non-small cell lung carcinoma | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 2 | NCT07329322 | Mar 2026 → Aug 2027 expected | non-small cell lung carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07466927 | Mar 2026 → Jan 2028 expected | Her2-receptor negative breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07471776 | Mar 2026 → Mar 2028 expected | Her2-receptor negative breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07388875 | Feb 2026 → Feb 2027 expected | small cell lung carcinoma | China Medical University, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07548060 | Feb 2026 → Jan 2028 expected | non-small cell lung carcinoma | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07348861 | Feb 2026 → Jan 2028 expected | cervical cancer | Zheng Min | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07256236 | Jan 2026 → Jun 2028 expected | cervical cancer | Fujian Cancer Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07341100 | Jan 2026 → Jan 2028 expected | malignant epithelial tumor of ovary | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07623577 | Jan 2026 → Jan 2027 expected | metastatic malignant neoplasm in the brain, triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07323056 | Jan → Jun 2026 overdue | non-small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Recruiting | No outcome recorded |
| Phase 2 | NCT07314619 | Dec 2025 → Dec 2027 expected | — | The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07371208 | Dec 2025 → Aug 2028 expected | breast cancer | Shanghai Jiao Tong University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT07343453 | Dec 2025 → Dec 2027 expected | thymic epithelial neoplasm | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07252739 | Dec 2025 → Nov 2029 expected | cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT07375316 | Dec 2025 → Jun 2028 expected | non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Recruiting | No outcome recorded |
| Phase 2 | NCT07244874 | Dec 2025 → Jan 2028 expected | triple-negative breast carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07244926 | Dec 2025 → Jun 2027 expected | lung cancer | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07193160 | Nov 2025 → Jul 2026 overdue | non-small cell lung carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07054242 | Oct 2025 → Oct 2026 expected | female breast carcinoma | Yantai Yuhuangding Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07197008 | Oct 2025 → Dec 2027 expected | lung cancer | Li-kun Chen | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07182721 | Sep 2025 → Sep 2028 expected | HER2 positive breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07179783 | Sep 2025 → Jun 2027 expected | castration-resistant prostate carcinoma, prostate adenocarcinoma, prostate neuroendocrine neoplasm | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07153965 | Sep 2025 → Sep 2026 overdue | triple-negative breast carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07128693 | Sep 2025 → Dec 2028 expected | esophageal squamous cell carcinoma | The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07109284 | Sep 2025 → Jan 2028 expected | estrogen-receptor positive breast cancer | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07007780 | Aug 2025 → Aug 2026 overdue | triple-negative breast carcinoma | Xijing Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07108816 | Aug 2025 → Dec 2026 expected | — | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07703228 | Aug 2025 → Sep 2027 expected | metastatic neoplasm, non-small cell lung carcinoma | Nanfang Hospital, Southern Medical University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07088211 | Jul 2025 → Aug 2027 expected | head and neck squamous cell carcinoma | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Recruiting | No outcome recorded |
| Phase 2 | NCT07105852 | Jul 2025 → Jul 2027 expected | cholangiocarcinoma | Sir Run Run Shaw Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06849492 | Apr 2025 → Dec 2027 expected | triple-negative breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06788912 | Mar 2025 → Feb 2032 expected | lung cancer | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05816252 | Apr 2023 → Jun 2026 overdue | non-small cell lung carcinoma | Klus Pharma Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05642780 | Jan 2023 → Nov 2027 expected | cancer | Klus Pharma Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05631262 | Nov 2022 → Dec 2026 expected | — | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active not recruiting | Met primary |
| Phase 2 | NCT05445908 | Aug 2022 → Sep 2027 expected | breast carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05351788 | May 2022 → Aug 2026 overdue | non-small cell lung carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 324 trials · 3 met primary | ||||||
| Phase 3 | NCT07628504 | May 2026 → Mar 2030 expected | — | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07419295 | Apr 2026 → Jul 2029 expected | urinary bladder cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07318558 | Feb 2026 → Feb 2033 expected | ovarian cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07216703 | Jan 2026 → Oct 2031 expected | cervical cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07071337 | Jul 2025 → Jul 2027 expected | Her2-receptor negative breast cancer | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06966700 | Jun 2025 → Mar 2033 expected | triple-negative breast carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06952504 | May 2025 → May 2032 expected | endometrial cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06824467 | Apr 2025 → Apr 2029 expected | fallopian tube cancer, ovarian cancer, peritoneum cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06841354 | Mar 2025 → May 2030 expected | triple-negative breast carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06670196 | Nov 2024 → May 2027 expected | non-small cell lung carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06711900 | Oct 2024 → Dec 2026 expected | non-small cell lung carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active not recruiting | Met primary |
| Phase 3 | NCT06459180 | Jul 2024 → Jun 2028 expected | cervical cancer | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06393374 | Jun 2024 → Dec 2030 expected | triple-negative breast carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06305754 | Jun 2024 → Aug 2028 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06448312 | Jun 2024 → Nov 2026 expected | non-small cell lung carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active not recruiting | Met primary |
| Phase 3 | NCT06356311 | May 2024 → Jan 2027 expected | gastroesophageal cancer | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06312176 | Apr 2024 → Jul 2027 expected | breast neoplasm | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06312137 | Apr 2024 → Feb 2034 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06279364 | Feb 2024 → Jul 2026 overdue | triple-negative breast carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06170788 | Dec 2023 → Jan 2028 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06132958 | Dec 2023 → Jan 2028 expected | endometrial cancer | Merck Sharp & Dohme LLC | Active not recruiting | Met primary |
| Phase 3 | NCT06074588 | Nov 2023 → May 2027 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06081959 | Oct 2023 → Dec 2026 expected | breast cancer | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05870319 | Jun 2023 → Jul 2024 overdue | non-small cell lung carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07068542 | Jul 2025 → Dec 2027 expected | differentiated thyroid carcinoma, poorly differentiated thyroid gland carcinoma | Zhejiang Provincial People's Hospital | Recruiting | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1/2 | NCT07157956 Background | Sep 2025 → Aug 2028 expected | neoplasm | Convalife (Shanghai) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06992739 Background | Dec 2025 → Mar 2027 expected | bone marrow failure syndrome, non-small cell lung carcinoma | The First Affiliated Hospital of Xiamen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06851299 Comparator | Mar 2025 → Apr 2027 expected | triple-negative breast carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT05347134 Comparator | Jun 2022 → Nov 2023 overdue | triple-negative breast carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active not recruiting | Met primary |
| Phase 4 | NCT06230055 Background | Jan 2024 → Jan 2026 overdue | Her2-receptor negative breast cancer, malignant leptomeningeal tumor | Fudan University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 48
| Date | Issuer | Release |
|---|---|---|
| 2026-08-04 | Merck Sharp & Dohme LLC | Results Merck & Co., Inc., Rahway, N.J., USA Announces Second-Quarter 2026 Financial Results; Highlights Key Regulatory and Clinical Milestones Across Broad, Diverse Pipeline merck.com ↗
Announced Positive Data From TroFuse-005 Trial Evaluating Sacituzumab Tirumotecan (sac-TMT) in Certain Patients With Advanced or Recurrent Endometrial Cancer |
| 2026-07-30 | Klus Pharma Inc. | Regulatory NMPA Accepts New Indication Application for Sacituzumab Tirumotecan (sac-TMT) as First-Line Treatment for Advanced TNBC kluspharma.com ↗
This marks the sixth indication application accepted by the NMPA for sac-TMT. |
| 2026-07-30 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory NMPA Accepts New Indication Application for Sacituzumab Tirumotecan (sac-TMT) as First-Line Treatment for Advanced TNBC kelun-biotech.com ↗
This marks the sixth indication application accepted by the NMPA for sac-TMT. |
| 2026-07-15 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Kelun-Biotech Announces Phase III Study of Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab as First-Line Treatment for PD-L1-Negative Non-Squamous NSCLC Met Primary Endpoint kelun-biotech.com ↗ |
| 2026-06-22 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Translational Research Results of Sacituzumab Tirumotecan (sac-TMT) in Combination with Osimertinib as First-Line Treatment for EGFR-Mutant NSCLC Published in Cancer Cell kelun-biotech.com ↗
The study shows that EGFR-TKIs induce TROP2 upregulation in DTP cells, providing a mechanistic basis for combining sac-TMT with EGFR-TKI. |
| 2026-06-22 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Translational Research Results of Sacituzumab Tirumotecan (sac-TMT) in Combination with Osimertinib as First-Line Treatment for EGFR-Mutant NSCLC Published in Cancer Cell kelun-biotech.com ↗
The study shows that trophoblast cell-surface antigen 2 (TROP2) expression is upregulated in residual drug-tolerant persister (DTP) cells after EGFR tyrosine kinase inhibitor (TKI) treatment; in preclinical models, sac-TMT combined with osimertinib inhibited DTP cell formation and delayed tumor recurrence. |
| 2026-05-31 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab for First-Line Treatment of PD-L1-Positive NSCLC Published in The Lancet kelun-biotech.com ↗
The study findings were also selected for an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8506, Lung Cancer – Metastatic Non-Small Cell). |
| 2026-05-30 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results The Results of Phase III OptiTROP-Lung05 Study of Sacituzumab Tirumotecan (sac-TMT) Presented as an ASCO Oral Presentation and Simultaneously Published in The Lancet kelun-biotech.com ↗ |
| 2026-05-21 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Kelun-Biotech Announces Phase III Trial of Sacituzumab Tirumotecan (sac-TMT) versus Chemotherapy as First‑line Treatment for Advanced TNBC Met Primary Endpoint of PFS kelun-biotech.com ↗
At this pre-specified interim analysis, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS. |
| 2026-05-18 | Merck Sharp & Dohme LLC | Results Merck Announces TroFuse-005 Trial Evaluating Sacituzumab Tirumotecan (Sac-TMT) Met Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Advanced or Recurrent Endometrial Cancer merck.com ↗
The study also reached its key secondary endpoint of objective response rate. |
| 2026-05-18 | Klus Pharma Inc. | Results Merck Announces TroFuse-005 Trial for Sac-TMT Met Primary Endpoints of OS and PFS in Advanced or Recurrent Endometrial Cancer kluspharma.com ↗
The study also reached its key secondary endpoint of objective response rate. |
| 2026-04-14 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Kelun-Biotech Announces Results from the SKB264-II-06/MK-2870-002 Study of Sacituzumab Tirumotecan (Sac-TMT) in Gynecologic Oncology Presented at 2026 SGO kelun-biotech.com ↗
The data showed that median progression-free survival (PFS) in the overall population was 20.9 months ; median overall survival (OS) was not reached; and the 12-month OS rate was 92%. |
| 2026-02-06 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory Kelun-Biotech Announces Fourth Indication for Sacituzumab Tirumotecan (sac-TMT) Approved by NMPA in HR+/HER2- Breast Cancer kelun-biotech.com ↗
This approval for HR+/HER2- BC after at least one prior line of chemotherapy marks the fourth indication for sac-TMT approved for marketing in China. |
| 2026-01-05 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory Kelun-Biotech Announces Breakthrough Therapy Designation Granted in China for Sacituzumab Tirumotecan (sac-TMT) in Combination with immunotherapy Pembrolizumab for First-Line Treatment of PD-L1-Positive NSCLC kelun-biotech.com ↗ |
| 2025-11-28 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results The Annals of Oncology Publishes Results of Phase II Study of Sacituzumab Tirumotecan Monotherapy for Urothelial Carcinoma kelun-biotech.com ↗
The results showed that sac-TMT 5 mg/kg monotherapy every 2 weeks demonstrated promising antitumor activity in participants with heavily pretreated advanced or metastatic UC, with a manageable safety profile, warranting further evaluation of sac-TMT in this population. |
| 2025-11-24 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Kelun-Biotech Announces Phase III Trial of Sac-TMT in Combination with KEYTRUDA® (pembrolizumab) as First-Line Treatment for PD-L1-Positive NSCLC Met Primary Endpoint kelun-biotech.com ↗
At a pre-specified interim analysis, the sac-TMT combination therapy demonstrated a statistically significant and clinically meaningful improvement in PFS. |
| 2025-10-20 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results The New England Journal of Medicine Publishes Results of Phase III OptiTROP-Lung04 Study of Sacituzumab Tirumotecan in Advanced EGFR-TKI-Resistant NSCLC kelun-biotech.com ↗
After a median follow-up of 18.9 months, the median PFS was 8.3 months in the sac-TMT group and 4.3 months in the chemotherapy group (hazard ratio (HR), 0.49; 95% confidence interval (CI), 0.39 to 0.62; two-sided P<0.0001). |
| 2025-10-18 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Positive Results from Phase 3 OptiTROP-Lung04 Trial of Sacituzumab Tirumotecan Presented at ESMO Presidential Symposium and Simultaneously Published in NEJM kelun-biotech.com ↗
Sac-TMT significantly improved PFS over chemotherapy with 51% lower risk of disease progression or death (hazard ratio (HR) 0.49; 95% confidence interval (CI), 0.39-0.62; P<0.0001). |
| 2025-10-18 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Kelun-Biotech Presents Positive Results of Phase 3 Clinical Study OptiTROP-Breast02 for Sacituzumab Tirumotecan in Advanced HR+/HER2- Breast Cancer at 2025 ESMO kelun-biotech.com ↗
As at the data cut-off date January 22, 2025, the median PFS was significantly longer in sac-TMT than in ICC (8.3 vs. 4.1 months; HR, 0.35; 95% CI, 0.26-0.48; P<0.0001). |
| 2025-10-11 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory Third Indication for Kelun-Biotech’s TROP2 ADC Sac-TMT Approved for Marketing by NMPA in EGFRm NSCLC Following Progression on EGFR-TKI Therapy kelun-biotech.com ↗ |
| 2025-08-19 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Nature Medicine Publishes Results of Phase II Study of Sacituzumab Tirumotecan Plus Tagitanlimab as First-Line Therapy for NSCLC kelun-biotech.com ↗ |
| 2025-05-22 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory Fourth NDA for Kelun-Biotech’s TROP2 ADC sacituzumab tirumotecan (sac-TMT) Accepted by the Center for Drug Evaluation kelun-biotech.com ↗
This acceptance is based on the positive results from the registrational phase 3 OptiTROP-Breast02 study, and the Application is the fourth indication application for sac-TMT that has been accepted by the NMPA. |
| 2025-03-10 | Klus Pharma Inc. | Regulatory Kelun-Biotech's TROP2 ADC Sacituzumab Tirumotecan (sac-TMT) Approved for Marketing in EGFRm NSCLC by NMPA kluspharma.com ↗
We are very pleased that the second indication of the Company's TROP2 ADC sacituzumab tirumotecan has been approved for marketing, which is exciting progress for us in the field of lung cancer. |
| 2025-01-13 | ChemRar Research and Development Institute, LLC | Regulatory Дайджест FDA (статусы Breakthrough therapy designation) — декабрь 2024 года chemrar.ru ↗
Компания Merck объявила, что FDA предоставило статус прорывной терапии (BTD) сацитузумабу тирумотекану (sacituzumab tirumotecan, sac-TMT) для лечения некоторых пациентов с немелкоклеточным раком легких (НМРЛ). |
| 2024-12-03 | Merck Sharp & Dohme LLC | Regulatory FDA Grants Breakthrough Therapy Designation to Sacituzumab Tirumotecan (sac-TMT) for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer With EGFR Mutations merck.com ↗
First breakthrough therapy designation for investigational sac-TMT in the U.S. |
| 2024-11-27 | Klus Pharma Inc. | Regulatory Kelun-Biotech’s TROP2 ADC Sacituzumab tirumotecan (sac-TMT, 佳泰莱®) Granted First Marketing Approval in China kluspharma.com ↗
This is the first domestically developed TROP2 ADC approved for marketing in China and the first domestically developed ADC fully approved for marketing in China. |
| 2024-11-27 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory Kelun-Biotech’s TROP2 ADC Sacituzumab tirumotecan (sac-TMT, 佳泰莱®) Approved For Marketing By NMPA Of China For 2L+ Advanced or Metastatic TNBC kelun-biotech.com ↗
This is the first domestically developed TROP2 ADC approved for marketing in China and the first domestically developed ADC fully approved for marketing in China. |
| 2024-10-31 | Klus Pharma Inc. | Regulatory Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) Third NDA for EGFR-mutant NSCLC Accepted by NMPA kluspharma.com ↗
The Application is the third NDA for sac-TMT that has been accepted by the NMPA. |
| 2024-10-31 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) Third NDA Accepted by NMPA, locally advanced or metastatic EGFR-mutant NSCLC kelun-biotech.com ↗
The Application is the third NDA for sac-TMT that has been accepted by the NMPA. |
| 2024-09-29 | Klus Pharma Inc. | Results Multiple Study Results of Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) Presented at 2024 CSCO Congress kluspharma.com ↗
The sac-TMT group had a 68% reduction in risk of disease progression or death compared to the chemotherapy group (HR 0.32; 95% CI, 0.22 to 0.44; P <0.00001). |
| 2024-09-29 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Multiple Study Results of Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) At 2024 CSCO Congress kelun-biotech.com ↗
The median OS was not reached (95% CI, 11.2 to NE) with SKB264 and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. |
| 2024-09-19 | Klus Pharma Inc. | Results Multiple Study Results for Kelun-Biotech's TROP2 ADC (Sac-TMT) Were Presented at 2024 ESMO Congress kluspharma.com ↗
38 patients had a median follow-up of 6.2 months with an ORR of 57.9% , including 3 complete remissions. |
| 2024-09-10 | Klus Pharma Inc. | Results Three Study Result Abstracts From Kelun-Biotech’s TROP2-ADC sac-TMT (SKB264) Released Today at 2024 ESMO kluspharma.com ↗
The abstracts for the above studies were published on the official website of the ESMO Congress on September 9, 2024, local time. |
| 2024-09-09 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Three Study Results Abstracts From Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) At 2024 ESMO Released Today kelun-biotech.com ↗
Clinical benefit was observed with sac-TMT versus TPC in this subgroup. |
| 2024-08-20 | Klus Pharma Inc. | Regulatory Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) Second NDA Accepted by NPMA, locally advanced or metastatic EGFR-mutant NSCLC kluspharma.com ↗
On August 20, the new drug application (NDA) for the core product sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) based on the positive results from the pivotal OptiTROP-Lung03 study has been accepted |
| 2024-08-20 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory Kelun-Biotech’s TROP2-ADC SKB264 (sac-TMT) Second NDA Accepted by NPMA, locally advanced or metastatic EGFR-mutant NSCLC kelun-biotech.com ↗
has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China |
| 2024-05-24 | Klus Pharma Inc. | Results Two Abstracts of SKB264/sac-TMT (TROP2 ADC) published at 2024 ASCO Annual Meeting kluspharma.com ↗
The abstracts for the above studies were published on ASCO’s official website on May 23, 2024, local time. |
| 2024-05-24 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results ASCO 2024| Two Abstracts of the Study Results of Kelun-Biotech’s TROP2-ADC SKB264/sac-TMT Published Today–OptiTROP-Breast01 study AND the OptiTROP-Lung01 study kelun-biotech.com ↗
The primary endpoint of progression free survival (PFS) was met based on interim analysis (data cut-off: Jun 21, 2023) with a 69% reduction in risk of progression or death (HR 0.31; 95 |
| 2024-03-13 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory The FOURTH BTD! TROP2-ADC SKB264 (MK-2870) Granted Breakthrough Therapy designation for 1L unresectable locally advanced, recurring or metastatic PD-L1 Negative TNBC by NMPA kelun-biotech.com ↗
On 8 th March 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK, Kelun-Biotech)’s innovative core product TROP2-ADC SKB264 (also known as MK-2870) was granted Breakthrough Therapy Designation（BTD） by the Center for Drug Evaluation（ CDE） of the National Medical Products Administration (NMPA) of China for first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative triple negative breast cancer (TNBC). |
| 2023-12-11 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory First TROP2-ADC in China! CDE Accepted the New Drug Application for SKB264 (MK-2870) kelun-biotech.com ↗
SKB264 new drug application has been included in the priority review and approval process by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). |
| 2023-12-07 | Klus Pharma Inc. | Results Kelun-Biotech Announces the Latest Clinical Study Results of SKB264 (MK-2870) for the Treatment of TNBC at 2023 SABCS kluspharma.com ↗
In addition, median progression-free survival (mPFS) was 5.7 months, and the median overall survival (mOS) reached 16.8 months, with 12-month and 24-month OS rates of 65% and 39.5%, respectively. |
| 2023-12-07 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results 2023 SABCS| Kelun-Biotech Announces the Latest Clinical Study Results of SKB264 (MK-2870) for the Treatment of Triple-negative Breast Cancer kelun-biotech.com ↗
In addition, median progression-free survival (mPFS) was 5.7 months, and the median overall survival (mOS) reached 16.8 months, with 12-month and 24-month OS rates of 65% and 39.5%, respectively. |
| 2023-08-14 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Kelun-Biotech announces that a Phase III clinical trial of SKB264 (MK-2870, TROP2-ADC) in unresectable locally advanced, recurrent or metastatic TNBC has met its primary endpoint kelun-biotech.com ↗
This clinical trial, which met its primary endpoint, is the first registrational Phase III study of SKB264 (MK-2870) in China. |
| 2023-06-19 | Klus Pharma Inc. | Regulatory SKB264 (MK-2870) is approved for clinical trials in the European Union kluspharma.com ↗ |
| 2023-06-16 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Regulatory SKB264 (MK-2870) is approved for clinical trials in the European Union kelun-biotech.com ↗ |
| 2023-05-27 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Kelun-Biotech to present recent clinical data for SKB264 (TROP2 ADC) at ASCO 2023 kelun-biotech.com ↗
Subgroup analysis showed that the ORR was 60% (12/20), the disease control rate (DCR) was 100% (20/20), and the median progression-free survival (PFS) was 11.1 months, with 9-month PFS rate of 66.7%. |
| 2023-05-26 | Klus Pharma Inc. | Results Kelun-Biotech to present recent clinical data for SKB264 (TROP2 ADC) at ASCO 2023 kluspharma.com ↗
Subgroup analysis showed that the ORR was 60% (12/20), the disease control rate (DCR) was 100% (20/20), and the median progression-free survival (PFS) was 11.1 months, with 9-month PFS rate of 66.7%. |
| 2022-12-14 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results 2022 SABCS | Kelun-Biotech TROP2-ADC (SKB264, MK-2870) Phase 2 Study Poster kelun-biotech.com ↗
Among 55 patients with evaluable response (21 in 4 mg/kg group, 34 in 5 mg/kg group), confirmed objective response rate (ORR) was 40% (22/55), disease control rate (DCR) was 80% (44/55), and confirmed ORR was 55.2% (16/29) in patients with high TROP2 expression. |
All press releases naming this drug 63 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 110 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sacituzumab tirumotecan | “A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of EGFR-mutant Locally Advanced or Metastatic Non-squamous...” NCT07854509 ↗89“The OptiTROP-Breast01 phase 3 trial assessed sacituzumab tirumotecan (sac-TMT) versus chemotherapy in patients with locally recurrent or metastatic TNBC who had received two or...” PMID 40217078 ↗ Apr 2025 “A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of Participants With Locally Advanced or Metastatic...” NCT07697586 ↗ “Sacituzumab tirumotecan (sac-TMT, also known as MK-2870 or SKB264) is an antibody-drug conjugate targeting trophoblast cell surface antigen 2.” PMID 40830660 ↗ Aug 2025 “Sacituzumab tirumotecan (sac-TMT), a trophoblast cell-surface antigen 2-targeting antibody-drug conjugate” PMID 42214392 ↗ May 2026 “Sacituzumab tirumotecan combined with third-generation EGFR-TKI with or without intracranial radiotherapy” NCT07343479 ↗ “Sacituzumab Tirumotecan (SKB264) Plus Glecirasib (KRAS G12C Inhibitor)” NCT07670013 ↗ “CVL006（B006 Injection）、SKB264（Sacituzumab tirumotecan）” NCT07157956 ↗ “sacituzumab tirumotecan 5 mg/kg IV q2w” NCT06145308 ↗ “Sacituzumab Tirumotecan (Sac-TMT)” NCT07371208 ↗ |
| Known as | Lukang-sacituzumab | “This study investigates the synergistic efficacy and safety of combining Lukang-sacituzumab (SKB264/MK-2870), a third-generation TROP2-directed antibody-drug conjugate (ADC),...” NCT07703228 ↗ |
| Known as | MK-2870 | “This study investigates the synergistic efficacy and safety of combining Lukang-sacituzumab (SKB264/MK-2870), a third-generation TROP2-directed antibody-drug conjugate (ADC),...” NCT07703228 ↗5“Sacituzumab tirumotecan (sac-TMT; MK-2870) is a novel antibody-drug conjugate (ADC) composed of a humanized anti-TROP2 monoclonal antibody linked to a topoisomerase I inhibitor...” NCT07815197 ↗ “A Prospective, Single-arm, Phase II Study of Neoadjuvant Sacituzumab Tirumotecan (SKB264/MK-2870) Combined With Toripalimab in Patients With Locally Advanced Esophageal...” NCT07823270 ↗ “A Phase 2 Non-comparative Screening Trial of Sacituzumab Tirumotecan (MK2870) Alone and in Combination With Pembrolizumab in Ovarian Clear Cell Carcinoma Previously Exposed to...” NCT07718854 ↗ “Sacituzumab tirumotecan (sac-TMT, also known as MK-2870 or SKB264) is an antibody-drug conjugate targeting trophoblast cell surface antigen 2.” PMID 40830660 ↗ Aug 2025 “sacituzumab tirumotecan (MK-2870)” NCT07511023 ↗ |
| Known as | sac-TMT | “This study is a Phase I, single-arm, single-center, dose-escalation clinical trial designed to investigate the safety and efficacy of intrathecal injection of sacituzumab...” NCT07702305 ↗19“This is an open-label, investigator-initiated phase II clinical trial designed to evaluate the efficacy and safety of Sacituzumab Tirumotecan (sac-TMT) monotherapy in patients...” NCT07521670 ↗ “Sacituzumab tirumotecan (sac-TMT, MK-2870) is a novel TROP-2-directed antibody-drug conjugate (ADC) composed of a humanized anti-TROP2 IgG1 monoclonal antibody linked via a...” NCT07804966 ↗ “The OptiTROP-Breast01 phase 3 trial assessed sacituzumab tirumotecan (sac-TMT) versus chemotherapy in patients with locally recurrent or metastatic TNBC who had received two or...” PMID 40217078 ↗ Apr 2025 “A Single Arm, Phase II Study of Sacituzumab Tirumotecan（Sac-TMT） Combined With Toripalimab for First-line Treatment of PD-L1 Positive Unresectable Locally Advanced/Metastatic...” NCT07244874 ↗ “This is an single-arm, multicenter phase II study to evaluate the safety and efficacy of Sacituzumab Tirumotecan (sac-TMT) plus anlotinib in previously treated extensive-stage...” NCT07501169 ↗ “Sacituzumab tirumotecan (sac-TMT; MK-2870) is a novel antibody-drug conjugate (ADC) composed of a humanized anti-TROP2 monoclonal antibody linked to a topoisomerase I inhibitor...” NCT07815197 ↗ “Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With Fruquintinib as Second-Line Therapy for Advanced Gastric/Gastroesophageal Junction...” NCT07689292 ↗ “An Open-label, Single-arm, Multicenter Phase I/II Study of Sacituzumab Tirumotecan (Sac-TMT) Plus Anlotinib in Previously Treated Metastatic Triple Negative Breast Cancer (mTNBC).” NCT07139470 ↗ “Sacituzumab tirumotecan (sac-TMT, also known as MK-2870 or SKB264) is an antibody-drug conjugate targeting trophoblast cell surface antigen 2.” PMID 40830660 ↗ Aug 2025 “Participants receive 400 mg of Pembrolizumab every 6 weeks, MK-1084 dose regimen, and 4 mg/kg sacituzumab tirumotecan (sac-TMT) every 2 weeks.” NCT07252739 ↗ |
| Known as | SKB264 | “A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of EGFR-mutant Locally Advanced or Metastatic Non-squamous...” NCT07854509 ↗35“This study investigates the synergistic efficacy and safety of combining Lukang-sacituzumab (SKB264/MK-2870), a third-generation TROP2-directed antibody-drug conjugate (ADC),...” NCT07703228 ↗ “Study Title: Safety and Efficacy of Intrathecal Injection of Sacituzumab Tirumotecan (SKB264) in the Treatment of Leptomeningeal Metastasis from EGFR-TKI-Resistant Non-Small...” NCT07702305 ↗ “A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of Participants With Locally Advanced or Metastatic...” NCT07697586 ↗ “A Prospective, Single-arm, Phase II Study of Neoadjuvant Sacituzumab Tirumotecan (SKB264/MK-2870) Combined With Toripalimab in Patients With Locally Advanced Esophageal...” NCT07823270 ↗ “Participants will receive treatment with a Trop-2-targeting ADC drug containing a TOP1 inhibitor (such as Gosituzumab or SKB264), in accordance with the defined protocol.” NCT06851299 ↗ “Sacituzumab tirumotecan (SKB264) 5 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles as neoadjuvant therapy, administered in combination with toripalimab.” NCT07819578 ↗ “Sacituzumab Tirumotecan (SKB264) is a humanized antibody-drug conjugate (ADC) targeting TROP2, which is often overexpressed in SCLC.” NCT07388875 ↗ “Sacituzumab Tirumotecan (SKB264): The initial dosage is 5 mg/kg, administered intravenously every two weeks.” NCT07579598 ↗ “Sacituzumab tirumotecan (Sac-TMT; also known as SKB264) for injection.” NCT07324629 ↗ “Sacituzumab Tirumotecan (Sac-TMT/SKB264) Plus Tagitanlimab (KL-A167)” NCT07701681 ↗ |
| Action | Deplete | “delivers treatment to destroy those cells.” NCT06952504 ↗ |
| Modality | Other / unclassified | “Sacituzumab tirumotecan (sac-TMT, also known as MK-2870 or SKB264) is an antibody-drug conjugate targeting trophoblast cell surface antigen 2.” PMID 40830660 ↗ Aug 2025 |
| Route | Intravenous | “Patients will receive study drug as a single IV infusion at the prescribed dose level at each administration.” NCT04152499 ↗ |