Drugs / Sacituzumab Tirumotecan
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Sacituzumab Tirumotecan

also known as SKB264 · Sac-TMT · MK-2870 · Lukang-sacituzumab

Other / unclassified

Developed for
non-small cell lung carcinoma · triple-negative breast carcinoma · cervical cancer · gastroesophageal junction adenocarcinoma · esophageal squamous cell carcinoma · breast cancer · gastric adenocarcinoma · Her2-receptor negative breast cancer
+42 more · lung cancer · small cell lung carcinoma · urothelial carcinoma · biliary tract cancer · endometrial cancer · esophageal cancer · gastroesophageal adenocarcinoma · head and neck squamous cell carcinoma · malignant epithelial tumor of ovary · metastatic malignant neoplasm in the brain · ovarian cancer · pancreatic ductal adenocarcinoma · prostate neuroendocrine neoplasm · salivary gland adenoid cystic carcinoma · urinary bladder cancer · breast carcinoma · breast neoplasm · cancer · castration-resistant prostate carcinoma · cholangiocarcinoma · colorectal cancer · differentiated thyroid carcinoma · endometrial carcinoma · estrogen-receptor positive breast cancer · fallopian tube cancer · female breast carcinoma · gastroesophageal cancer · head and neck carcinoma · HER2 positive breast carcinoma · metastatic neoplasm · neoplastic meningitis · non-invasive bladder urothelial carcinoma · poorly differentiated thyroid gland carcinoma · primary peritoneal carcinoma · prostate adenocarcinoma · prostate cancer · salivary gland carcinoma · SMARCB1-deficient kidney medullary carcinoma · squamous cell carcinoma · thymic carcinoma · thymic epithelial neoplasm · thyroid gland papillary carcinoma
Investigated by
Merck Sharp & Dohme LLC · Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Fudan University · Tianjin Medical University Cancer Institute and Hospital · European Network of Gynaecological Oncological Trial Groups (ENGOT) · GOG Foundation
+56 more · Daiichi Sankyo · Klus Pharma Inc. · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Henan Cancer Hospital · M.D. Anderson Cancer Center · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Sun Yat-sen University · The First Affiliated Hospital of Zhengzhou University · Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Affiliated Hospital of Jiaxing University · Biying Chen · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · China Medical University, China · Clario · Department of Obstetrics and Gynecology, Affiliated Dongguan People's Hospital, Southern Medical University · Discovery Life Sciences, LLC · Frontage Laboratories, Inc. · Fujian Cancer Hospital · Guangdong Association of Clinical Trials · Hunan Province Tumor Hospital · Huzhou Central Hospital · Johns Hopkins University · Li-kun Chen · Myriad Genetics, Inc. · Nanfang Hospital, Southern Medical University · National Cancer Center, Japan · National Cancer Centre, Singapore · Ningbo Medical Center Lihuili Hospital · Peking Union Medical College · Peking Union Medical College Hospital · Peking University Hospital of Stomatology · Qilu Pharmaceutical Co., Ltd. · Ruijin Hospital · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shanghai Jiao Tong University School of Medicine · Shanghai Pulmonary Hospital, Shanghai, China · Shenzhen Hospital, Guangzhou University of Chinese Medicine · Sichuan University · Sir Run Run Shaw Hospital · Southwest Hospital, China · Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · The Central Hospital of Huanggang · The First Affiliated Hospital of University of Science and Technology of China · The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Tianjin Medical University Second Hospital · Translational Breast Cancer Research Consortium · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Ventana Medical Systems, Inc · Virginia Commonwealth University · West China Hospital · Xijing Hospital · Yale University · Yantai Yuhuangding Hospital · Zhejiang Cancer Hospital · Zhejiang Provincial People's Hospital · Zheng Min

Trials 93 · started per year

today
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202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 → Jun 2026 overdue non-small cell lung carcinoma Merck Sharp & Dohme LLC Active not recruiting No outcome recorded
Phase 1/210 trials
Phase 1/2 NCT07286149 Apr 2026 → Aug 2031 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 → Dec 2026 expected breast cancer, cervical cancer, endometrial carcinoma, gastric adenocarcinoma +6 Klus Pharma Inc. Active not recruiting No outcome recorded
Phase 255 trials
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 NCT07511023 Sep 2026 → Mar 2031 expected squamous cell carcinoma M.D. Anderson Cancer Center 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 NCT07639086 Aug 2026 → Mar 2030 expected prostate cancer, prostate neuroendocrine neoplasm Virginia Commonwealth 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 NCT07662863 Jul 2026 → Dec 2028 expected peripheral neuropathy, urinary bladder cancer, urothelial carcinoma Fudan University 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 NCT07686588 Jul 2026 → Dec 2027 expected head and neck carcinoma Biying Chen Not yet recruiting No outcome recorded
Phase 2 NCT07438626 Jun 2026 → Jun 2028 expected SMARCB1-deficient kidney medullary carcinoma M.D. Anderson Cancer Center Not yet recruiting No outcome recorded
Phase 325 trials
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, primary peritoneal carcinoma 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 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
Also used as a comparator or background therapy in 5 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT07157956 Background Sep 2025 → Aug 2028 expected neoplasm Convalife (Shanghai) Co., Ltd. Not yet recruiting No outcome recorded
Phase 22 trials
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 31 trial
Phase 3 NCT05347134 Comparator Jun 2022 → Nov 2023 overdue triple-negative breast carcinoma Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Phase 41 trial
Phase 4 NCT06230055 Background Jan 2024 → Jan 2026 overdue Her2-receptor negative breast cancer, malignant leptomeningeal tumor Fudan University Recruiting No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 99 sources stand behind the page.

FieldValueCited text
Known as Sacituzumab tirumotecan “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
78

“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 combined with third-generation EGFR-TKI with or without intracranial radiotherapy” NCT07343479

Sacituzumab tirumotecan (sac-TMT), a trophoblast cell-surface antigen 2-targeting antibody-drug conjugate” PMID 42214392 May 2026

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

NCT06966700

NCT07256236

NCT07179783

NCT07286149

NCT06952504

NCT07329322

NCT07701122

NCT07375316

NCT06992739

NCT06428409

NCT07579598

NCT07088211

NCT07628504

NCT07639086

NCT07105852

NCT07318558

NCT06459180

NCT07419295

NCT07703228

NCT07348861

NCT06305754

NCT07388875

NCT06706219

NCT07193160

NCT07702305

NCT07324629

NCT07153965

NCT06049212

NCT06469944

NCT07007780

NCT06393374

NCT05319730

NCT07054242

NCT07128693

NCT07216703

NCT07197008

NCT07244926

NCT07471776

NCT07689292

NCT06637423

NCT07548060

NCT07068542

NCT07244874

NCT06312137

NCT07686588

NCT06356311

NCT07501169

NCT07314619

NCT06132958

NCT07343453

NCT06483334

NCT06841354

NCT07458113

NCT07701681

NCT07662863

NCT07521670

NCT07139470

NCT07623577

NCT07511023

NCT06074588

NCT06312176

NCT06824467

NCT06780111

NCT07108816

NCT07109284

NCT07561463

NCT07438626

NCT07323056

NCT06445972

NCT06170788

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
2

“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
18

“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

“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

“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

“Sacituzumab Tirumotecan (sac-TMT) is administered intravenously at a dose of 4 mg/kg on Day 1 of each 3-week cycle for a total of 8 cycles.” NCT07628504

“Sacituzumab tirumotecan (sac-TMT), a trophoblast cell-surface antigen 2-targeting antibody-drug conjugate” PMID 42214392 May 2026

“Sacituzumab tirumotecan (sac-TMT) is an antibody-drug conjugate (ADC) directed against TROP2.” NCT07639086

“Sacituzumab tirumotecan (Sac-TMT; also known as SKB264) for injection.” NCT07324629

“Sacituzumab Tirumotecan (Sac-TMT/SKB264) Plus Tagitanlimab (KL-A167)” NCT07701681

“Sacituzumab Tirumotecan (Sac-TMT) plus Tagitanlimab” NCT07153965

“Sacituzumab tirumotecan (Sac-TMT) plus bevacizumab” NCT07197008

“Biological: Sacituzumab Tirumotecan (sac-TMT)” NCT06469944

“Sacituzumab Tirumotecan (Sac-TMT)” NCT07623577

“Sacituzumab Tirumotecan (Sac-TMT)” NCT07371208

NCT06422143

Known as SKB264 “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
29

“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

“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) 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

“Drug: Sacituzumab Tirumotecan (SKB264)” NCT07701122

“Sacituzumab Tirumotecan (SKB264)” NCT07068542

SKB264(5mg/kg, d1, q2w, ivgtt)” NCT06230055

NCT07341100

NCT05347134

NCT06849492

NCT07466927

NCT07071337

NCT04152499

NCT07670013

NCT07182721

NCT05870319

NCT06711900

NCT07157956

NCT05642780

NCT05816252

NCT06081959

NCT05631262

NCT05445908

NCT07545213

NCT06279364

NCT06670196

Action Deplete “attaches to specific targets on cancer cells and delivers treatment to destroy those cells” NCT07216703
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