Drugs / Sacituzumab Govitecan
Sacituzumab Govitecan
also known as
Sacituzumab Govitecan-hziy · IMMU-132 · Trodelvy · hRS7-SN38 · HRS7-SN38-ANTIBODY-DRUG-CONJUGATE · SG
Monoclonal antibody targets TACSTD2, TOP1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (5) | US (FDA) | TRODELVY | — | 2021-04-07 – 2026-06-24 | fda.gov ↗ |
| Approved | EU (EMA) | Trodelvy | — | 2021-11-22 | europa.eu ↗ |
| Approved | US (FDA) | TRODELVY | — | 2020-04-22 | fda.gov ↗ |
Trials 127 · started per year
today
US approved 2020
EU approved 2021
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03995706 | Jul 2019 → Jun 2022 | glioblastoma | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 19 trials | ||||||
| Phase 1 | NCT07674615 | Jul 2026 → Jun 2027 expected | fallopian tube carcinoma, malignant epithelial tumor of ovary, primary peritoneal carcinoma | Shanghai Gynecologic Oncology Group | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07163481 | Oct 2025 → Dec 2026 expected | female breast carcinoma | Hunan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06065371 | Nov 2024 → Dec 2026 expected | digestive system cancer | Henry Ford Health System | Recruiting | No outcome recorded |
| Phase 1 | NCT05833867 | Apr 2024 → Dec 2026 expected | infiltrating bladder urothelial carcinoma | Shilpa Gupta, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT06167317 | Jan 2024 → Sep 2028 expected | cancer | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 1 | NCT05774886 | May → Sep 2023 | female breast carcinoma, triple-negative breast carcinoma | Dana-Farber Cancer Institute | Withdrawn | No outcome recorded |
| Phase 1 | NCT05143229 | Mar 2022 → Jan 2025 overdue | breast cancer | University of Kansas Medical Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04794699 | Apr 2021 → Jan 2027 expected | cancer | IDEAYA Biosciences | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04617522 | Apr 2021 → Dec 2026 expected | liver failure | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 1/222 trials | ||||||
| Phase 1/2 | NCT07328490 | Apr 2026 | small cell lung carcinoma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT06462092 | Jan 2026 → Jan 2027 expected | malignant leptomeningeal tumor | Guangzhou Medical University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07011654 | Sep 2025 → Jul 2028 expected | triple-negative breast carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06926920 | Apr 2025 → Jun 2028 expected | triple-negative breast carcinoma | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06827613 | Mar 2025 → Jan 2027 expected | hormone receptor-positive breast cancer, triple-negative breast carcinoma | Marengo Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06238921 | Dec 2024 → Feb 2027 expected | triple-negative breast carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06123468 | Apr 2024 → Jan 2026 | gastroesophageal adenocarcinoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Completed | No outcome recorded |
| Phase 1/2 | NCT06328387 | Jan 2024 → Feb 2026 | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 1/2 | NCT05867251 | Aug 2023 → Jan 2028 expected | endometrial cancer, fallopian tube cancer, hormone receptor-positive breast cancer, malignant epithelial tumor of ovary +2 | Avenzo Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05101096 | Oct 2021 → May 2027 expected | hormone receptor-positive breast cancer, triple-negative breast carcinoma, urothelial carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04826341 | Sep 2021 → Mar 2028 expected | disease of genetic or genomic mechanism, small cell lung carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04927884 | Sep 2021 → Sep 2022 | triple-negative breast carcinoma | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT04724018 | May 2021 → Feb 2027 expected | renal pelvis/ureter urothelial carcinoma, urinary bladder cancer | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04863885 | Apr 2021 → Sep 2025 overdue | urothelial carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04381832 | Jul 2020 → Aug 2024 | castration-resistant prostate carcinoma | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04143711 | Nov 2019 → Dec 2025 | cancer | Dragonfly Therapeutics | Completed | No outcome recorded |
| Phase 1/2 | NCT04039230 | Oct 2019 → Jan 2027 expected | breast cancer | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03992131 | Jun 2019 → Mar 2022 | ovarian cancer, triple-negative breast carcinoma, urothelial carcinoma | pharmaand GmbH | Terminated | No outcome recorded |
| Phase 1/2 | NCT03869190 | Jun 2019 → Oct 2025 | urinary bladder cancer, urothelial carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT03424005 | Mar 2018 → Sep 2030 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03337698 | Dec 2017 → Oct 2025 | non-small cell lung carcinoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1/2 | NCT01631552 | Dec 2012 → Mar 2019 | cervical cancer, endometrial cancer, esophageal cancer, gastric adenocarcinoma +11 | Gilead Sciences | Completed | No outcome recorded |
| Phase 273 trials | ||||||
| Phase 2 | NCT07504588 | Sep 2026 → Apr 2029 expected | fallopian tube endometrioid adenocarcinoma, fallopian tube serous adenocarcinoma, ovarian endometrioid adenocarcinoma, primary peritoneal serous adenocarcinoma | National Cancer Institute (NCI) | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07393555 | Aug 2026 → Nov 2028 expected | non-small cell lung carcinoma | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07367178 | Jul 2026 → Jun 2027 expected | hormone receptor-positive breast cancer, triple-negative breast carcinoma | MedSIR | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07339059 | Jun 2026 → Feb 2029 expected | small cell lung carcinoma | Bindu R Potugari | Recruiting | No outcome recorded |
| Phase 2 | NCT07492914 | May → Dec 2026 expected | head and neck squamous cell carcinoma | West China Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07134556 | Apr 2026 → May 2028 | triple-negative breast carcinoma | MedSIR | Withdrawn | No outcome recorded |
| Phase 2 | NCT06889610 | Mar 2026 → Dec 2027 expected | colorectal cancer, melanoma, triple-negative breast carcinoma | Fudan University | 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 | NCT07438600 | Feb 2026 → Feb 2027 expected | non-small cell lung carcinoma | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07368543 | Jan 2026 → Jun 2027 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07271992 | Dec 2025 → Dec 2030 expected | triple-negative breast carcinoma | First Hospital of China Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07299409 | Dec 2025 → Aug 2027 expected | triple-negative breast carcinoma | British Columbia Cancer Agency | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07151586 | Oct 2025 → Oct 2029 expected | metastatic malignant neoplasm, triple-negative breast carcinoma | UNICANCER | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07040644 | Sep 2025 → Jun 2027 expected | triple-negative breast carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07077564 | Jul 2025 → Jul 2027 expected | neuroendocrine neoplasm | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07063212 | Jul 2025 → Jan 2028 expected | hypopharynx squamous cell carcinoma, laryngeal squamous cell carcinoma, nasal cavity cancer, oral cavity squamous cell carcinoma +2 | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07657130 | Jul 2025 → Jun 2026 overdue | female breast carcinoma | Liaoning Cancer Hospital & Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06865677 | Jun → Jul 2025 | cervical carcinoma, endometrial carcinoma, ovarian carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT06401824 | Apr 2025 → Nov 2026 expected | metastatic malignant neoplasm in the brain, non-small cell lung carcinoma | Maastricht University Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06923826 | Apr 2025 → Apr 2030 expected | salivary gland cancer, thyroid cancer | National University Hospital, Singapore | Recruiting | No outcome recorded |
| Phase 2 | NCT06665178 | Mar 2025 → May 2027 expected | breast cancer | British Columbia Cancer Agency | Recruiting | No outcome recorded |
| Phase 2 | NCT06311214 | Mar 2025 → Mar 2028 expected | metastatic malignant neoplasm | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06133517 | Jan 2025 → Jan 2030 expected | infiltrating bladder urothelial carcinoma | Fundación para el Progreso de la Oncología en Cantabria | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06667167 | Dec 2024 → Nov 2027 expected | non-small cell lung carcinoma | Nir Peled | Recruiting | No outcome recorded |
| Phase 2 | NCT06793332 | Dec 2024 → Jan 2026 overdue | metastatic malignant neoplasm in the brain, triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06878625 | Dec 2024 → Jun 2027 expected | — | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06528483 | Dec 2024 → Dec 2026 expected | infiltrating bladder urothelial carcinoma | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06682728 | Nov 2024 → Dec 2026 expected | urothelial carcinoma | University of California, Irvine | Recruiting | No outcome recorded |
| Phase 2 | NCT06739395 | Nov 2024 → Dec 2026 expected | cancer | Tianjin Medical University Second Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06235216 | Sep 2024 → Dec 2027 expected | differentiated thyroid carcinoma, thyroid gland undifferentiated (anaplastic) carcinoma | Spanish Group for Research in Neuroendocrine Tumors | Recruiting | No outcome recorded |
| Phase 2 | NCT06409390 | Aug 2024 → Apr 2027 expected | breast cancer | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06161532 | Aug 2024 → Nov 2027 expected | bladder adenocarcinoma, bladder small cell carcinoma, bladder squamous cell carcinoma, kidney medullary carcinoma +2 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06329869 | Aug 2024 → Nov 2026 expected | esophageal squamous cell carcinoma | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06477419 | Jun 2024 → Jun 2029 expected | pleural mesothelioma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06263543 | Jun 2024 → Jun 2026 overdue | hormone receptor-positive breast cancer | Reshma L. Mahtani, D.O. | Recruiting | No outcome recorded |
| Phase 2 | NCT06462079 | Jun 2024 → Jan 2027 expected | metastatic malignant neoplasm in the brain | Guangzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06248515 | Apr 2024 → Apr 2026 overdue | thymic carcinoma, thymoma | Georgetown University | Recruiting | No outcome recorded |
| Phase 2 | NCT07359404 | Apr 2024 → Dec 2026 expected | breast cancer | YING FAN | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT06236269 | Mar 2024 → Feb 2026 overdue | breast cancer | SOLTI Breast Cancer Research Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06055465 | Feb 2024 → Dec 2028 expected | lung cancer | Chinese University of Hong Kong | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06178588 | Feb 2024 → Mar 2026 overdue | hilar cholangiocarcinoma | University of Kansas Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06028932 | Jan 2024 → Nov 2026 expected | ovarian carcinoma | Yale University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06100874 | Nov 2023 → Feb 2026 overdue | HER2 positive breast carcinoma, female breast carcinoma | Adrienne G. Waks | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05770531 | Oct 2023 → Aug 2028 expected | triple-negative breast carcinoma | Vanderbilt-Ingram Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05535218 | Sep 2023 → Feb 2027 expected | infiltrating bladder urothelial carcinoma | Claudia Guerrieri | 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 | NCT05884320 | Jul 2023 → Jul 2028 expected | salivary gland cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05332561 | Jun 2023 → Mar 2030 expected | female breast carcinoma | German Cancer Research Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05581589 | Jun 2023 → Oct 2024 | infiltrating bladder urothelial carcinoma | University of Washington | Terminated | No outcome recorded |
| Phase 2 | NCT05601440 | Jun 2023 → Dec 2027 expected | female breast carcinoma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT05838521 | Jun 2023 → Jun 2026 overdue | cervical cancer | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT05675579 | May 2023 → Dec 2026 expected | breast cancer | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05633667 | Mar 2023 → Sep 2029 expected | non-small cell lung carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05520723 | Feb → Oct 2023 | hormone receptor-positive breast cancer, triple-negative breast carcinoma | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT05327530 | Aug 2022 → Jun 2025 overdue | urothelial carcinoma | EMD Serono Research & Development Institute, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05186974 | May 2022 → Sep 2026 expected | non-small cell lung carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05097599 | Apr 2022 → Jun 2024 | cancer | Strata Oncology | Terminated | No outcome recorded |
| Phase 2 | NCT05226117 | Mar 2022 → Sep 2025 | urothelial carcinoma | IRCCS San Raffaele | Completed | No outcome recorded |
| Phase 2 | NCT04559230 | Jan 2022 → Feb 2027 expected | glioblastoma | The University of Texas Health Science Center at San Antonio | Recruiting | No outcome recorded |
| Phase 2 | NCT04958785 | Dec 2021 → Oct 2024 | triple-negative breast carcinoma | Gilead Sciences | Terminated | No outcome recorded |
| Phase 2 | NCT05119907 | Oct 2021 → Oct 2026 expected | cancer | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04647916 | Jun 2021 → Dec 2027 expected | Her2-receptor negative breast cancer, female breast carcinoma, invasive breast carcinoma, metastatic malignant neoplasm in the brain | SWOG Cancer Research Network | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04454437 | Oct 2020 → Aug 2021 overdue | triple-negative breast carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04448886 | Sep 2020 → Mar 2024 overdue | hormone receptor-positive breast cancer, invasive breast carcinoma | Ana C Garrido-Castro, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04468061 | Jul 2020 → Apr 2027 expected | triple-negative breast carcinoma | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04230109 | Jul 2020 → Oct 2028 expected | invasive breast carcinoma, triple-negative breast carcinoma | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04434040 | Jul 2020 → Dec 2026 expected | triple-negative breast carcinoma | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04251416 | Mar 2020 → Dec 2026 expected | endometrial carcinoma | Yale University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03964727 | Oct 2019 → Jan 2025 overdue | metastatic neoplasm | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03971409 | Jul 2019 → Jan 2027 expected | female breast carcinoma, invasive breast carcinoma, triple-negative breast carcinoma | Laura Huppert, MD, BA | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03725761 | Oct 2018 → Apr 2024 overdue | prostate cancer | University of Wisconsin, Madison | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03547973 | Aug 2018 → Apr 2030 expected | urothelial carcinoma | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT02161679 | Aug 2016 | triple-negative breast carcinoma | Gilead Sciences | Withdrawn | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06243393 | Apr 2024 → Aug 2028 expected | colorectal cancer | University Hospital Heidelberg | Recruiting | No outcome recorded |
| Phase 318 trials | ||||||
| Phase 3 | NCT07178730 | Jun 2026 → Mar 2033 expected | triple-negative breast carcinoma | West German Study Group | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06524544 | Dec 2025 → Dec 2028 expected | urothelial carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 3 | NCT06801834 | Apr 2025 → Oct 2029 expected | small cell lung carcinoma | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 3 | NCT06431633 | Feb 2025 → Nov 2031 expected | non-small cell lung carcinoma | Fundación GECP | Recruiting | No outcome recorded |
| Phase 3 | NCT06081244 | Oct 2024 → Sep 2029 expected | triple-negative breast carcinoma | West German Study Group | Recruiting | No outcome recorded |
| Phase 3 | NCT06486441 | Aug 2024 → Jun 2029 expected | endometrial cancer | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05552001 | Oct 2023 → May 2026 overdue | triple-negative breast carcinoma | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT05840211 | May 2023 → Apr 2028 expected | breast cancer | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05609968 | Feb 2023 → Jan 2027 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05633654 | Dec 2022 → Jun 2027 expected | triple-negative breast carcinoma | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 3 | NCT05382286 | Jul 2022 → Feb 2027 expected | triple-negative breast carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05382299 | Jul 2022 → Jul 2028 expected | triple-negative breast carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05089734 | Nov 2021 → Nov 2023 overdue | non-small cell lung carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04527991 | Jan 2021 → Jul 2025 | urothelial carcinoma | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT04639986 | Nov 2020 → Dec 2026 expected | breast cancer | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04595565 | Oct 2020 → Mar 2027 expected | triple-negative breast carcinoma | GBG Forschungs GmbH | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03901339 | May 2019 → Oct 2023 | breast cancer | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02574455 | Nov 2017 → Mar 2020 | breast cancer | Gilead Sciences | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07162259 | Oct 2025 → Dec 2027 expected | breast cancer | Yan Xue | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04319198 | Aug 2020 → Oct 2024 | metastatic neoplasm | Gilead Sciences | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06341478 | Mar 2024 → Mar 2026 overdue | urinary bladder cancer | IRCCS San Raffaele | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 18 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05006794 Background | Sep 2021 → Jun 2025 | cancer | Gilead Sciences | Terminated | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06963905 Comparator | Dec 2025 → Dec 2030 expected | triple-negative breast carcinoma | Yale University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06612203 Background | Jan 2025 → Feb 2027 expected | breast cancer | MedSIR | Active not recruiting | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT07474558 Background | Sep 2026 → Jan 2030 expected | alopecia, metastatic neoplasm | Jules Bordet Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07394218 Background | Dec 2025 → Mar 2028 expected | Her2-receptor negative breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06616987 Background | Jul 2025 → Jun 2027 expected | breast carcinoma | Yeon Hee Park | Recruiting | No outcome recorded |
| Phase 2 | NCT06102824 Comparator | Oct 2024 → Jun 2027 expected | Her2-receptor negative breast cancer | Guangdong Provincial People's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05008510 Comparator | Dec 2021 → Jul 2022 | triple-negative breast carcinoma | Veru Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT05113966 Background | Dec 2021 → Nov 2023 | triple-negative breast carcinoma | G1 Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT04986579 Background | Oct 2021 → Jun 2028 expected | breast cancer, chemotherapy-induced alopecia | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT03606967 Background | Apr 2021 → Dec 2026 expected | invasive breast carcinoma, triple-negative breast carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07533123 Comparator | Mar 2026 → Mar 2029 expected | triple-negative breast carcinoma | Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT07461454 Comparator | Mar 2026 → Dec 2027 expected | breast cancer | MediLink Therapeutics (Suzhou) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07371910 Comparator | Jun 2024 → Mar 2031 expected | Her2-receptor negative breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04579224 Comparator | Jun 2021 → Aug 2030 expected | urinary bladder carcinoma, urothelial carcinoma | National Cancer Institute (NCI) | 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 |
| Phase not applicable1 trial | ||||||
| — | NCT07046455 Background | Mar 2025 → Mar 2027 expected | triple-negative breast carcinoma | Peking University Cancer Hospital & Institute | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04320693 Background | — | triple-negative breast carcinoma | Gilead Sciences | Approved for marketing | No outcome recorded |
Press releases naming this drug 42 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-24 | Gilead Sciences | CHMP Recommends Gilead’s Trodelvy® Plus Keytruda® in PD-(L)1-Positive First-Line Metastatic Triple-Negative Breast Cancer gilead.com ↗ |
| 2026-06-24 | Gilead Sciences | U.S. FDA Approves Trodelvy® for First-Line Treatment of Metastatic Triple-Negative Breast Cancer gilead.com ↗ |
| 2026-06-23 | Gilead Sciences | European Commission Approves Trodelvy® as a First-Line Treatment for Metastatic Triple-Negative Breast Cancer Patients Not Candidates for PD-(l)1 Inhibitors gilead.com ↗ |
| 2026-05-22 | Gilead Sciences | Gilead Receives CHMP Positive Opinion for Trodelvy® in First-Line Metastatic Triple-Negative Breast Cancer for Patients Not Candidates for PD-(L)1 Inhibitors gilead.com ↗ |
| 2026-01-21 | Gilead Sciences | New England Journal of Medicine Publishes Phase 3 ASCENT-04/KEYNOTE-D19 Results Supporting Trodelvy® Plus Keytruda® as a Potential New Standard of Care in First-line PD-L1+ Metastatic Triple-negative Breast Cancer gilead.com ↗ |
| 2025-10-19 | Gilead Sciences | Trodelvy® Reduces Risk of Disease Progression or Death by 38% Versus Chemotherapy as First-Line Therapy in Patients With Metastatic Triple-Negative Breast Cancer in ASCENT-03 Study gilead.com ↗ |
| 2025-05-31 | Gilead Sciences | Trodelvy® Plus Keytruda® Reduces Risk of Disease Progression or Death by 35% Versus Keytruda and Chemotherapy in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer gilead.com ↗ |
| 2025-05-23 | Gilead Sciences | ASCENT-03: Trodelvy® Demonstrates Highly Statistically Significant & Clinically Meaningful Improvement in Progression Free Survival in Patients With First-line Metastatic Triple-Negative Breast Cancer Who Are Not Candidates for Checkpoint Inhibitors gilead.com ↗ |
| 2025-04-21 | Gilead Sciences | Trodelvy® Plus Keytruda® Demonstrates a Statistically Significant and Clinically Meaningful Improvement in Progression Free Survival in Patients With Previously Untreated PD-L1+ Metastatic Triple-Negative Breast Cancer gilead.com ↗ |
| 2024-12-17 | Gilead Sciences | U.S. FDA Grants Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for Second-Line Treatment of Extensive-Stage Small Cell Lung Cancer gilead.com ↗ |
| 2024-09-05 | Gilead Sciences | Gilead to Present New Trodelvy® Data at the IASLC 2024 World Conference on Lung Cancer gilead.com ↗ |
| 2023-11-30 | Gilead Sciences | Gilead’s Leadership in Metastatic Breast Cancer Showcased With New Trodelvy Data at San Antonio Breast Cancer Symposium 2023 gilead.com ↗ |
| 2023-09-10 | Gilead Sciences | Gilead’s Phase 2 EVOKE-02 Study of Trodelvy® (sacituzumab govitecan-hziy) in Combination With KEYTRUDA® (pembrolizumab) Demonstrates Promising Clinical Activity in First-Line Metastatic Non-Small Cell Lung Cancer gilead.com ↗ |
| 2023-07-27 | Gilead Sciences | European Commission Approves Gilead’s Trodelvy® For Pre-Treated HR+/HER2- Metastatic Breast Cancer gilead.com ↗ |
| 2023-06-23 | Gilead Sciences | Gilead Receives CHMP Positive Opinion for Trodelvy® in Pre-Treated HR+/HER2- Metastatic Breast Cancer gilead.com ↗ |
| 2023-06-05 | Gilead Sciences | Trodelvy® Continues to Show Durable Overall Survival Advantage in Pre-Treated HR+/HER2- Metastatic Breast Cancer gilead.com ↗ |
| 2023-02-17 | Gilead Sciences | Trodelvy® Demonstrates Positive Efficacy Treating Both Platinum-Ineligible and Rapidly Progressing, Post-Platinum Metastatic Urothelial Cancer gilead.com ↗ |
| 2023-02-03 | Gilead Sciences | U.S. FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer gilead.com ↗ |
| 2023-01-03 | Gilead Sciences | European Medicines Agency Validates Marketing Authorization Application For Trodelvy® (sacituzumab govitecan-hziy) For Pre-treated HR+/HER2- Metastatic Breast Cancer gilead.com ↗ |
| 2022-12-06 | Gilead Sciences | New Data for Trodelvy Demonstrate Clinical Efficacy Across Trop-2 Expression Levels in HR+/HER2- Metastatic Breast Cancer gilead.com ↗ |
| 2022-10-11 | Gilead Sciences | U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Gilead’s Trodelvy® for Pre-Treated HR+/HER2- Metastatic Breast Cancer gilead.com ↗ |
| 2022-09-07 | Gilead Sciences | Trodelvy® Significantly Improved Overall Survival in Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients in TROPiCS-02 Study gilead.com ↗ |
| 2022-09-04 | Gilead Sciences | New TROPiCS-02 Data in HR+/HER2- Metastatic Breast Cancer Patients Demonstrates Progression-Free Survival Benefit of Trodelvy® Regardless of Their HER2 Status gilead.com ↗ |
| 2022-08-15 | Gilead Sciences | Trodelvy® Significantly Improves Overall Survival in Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients in the TROPiCS-02 Study gilead.com ↗ |
| 2022-08-15 | Gilead Sciences | Gilead to Acquire Remaining Worldwide Rights of Trodelvy® gilead.com ↗ |
| 2022-06-06 | Gilead Sciences | Final Data From Phase 3 ASCENT Study Demonstrates Trodelvy Extends Overall Survival Over Chemotherapy in Second-Line Metastatic TNBC gilead.com ↗ |
| 2022-06-04 | Gilead Sciences | Trodelvy® Improved Progression-Free Survival by 34% in Heavily Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients gilead.com ↗ |
| 2022-01-10 | Gilead Sciences | Gilead Announces Clinical Trial Collaborations With Merck to Evaluate Trodelvy® in Combination With KEYTRUDA® in First-Line Metastatic Non-Small Cell Lung Cancer gilead.com ↗ |
| 2021-12-10 | Gilead Sciences | Trodelvy® Demonstrates Clinical Benefit for Black Patients Consistent with Full Metastatic Triple-Negative Breast Cancer Population in ASCENT Study gilead.com ↗ |
| 2021-11-23 | Gilead Sciences | Trodelvy® (sacituzumab govitecan) Granted European Commission Marketing Authorization for Treatment of Metastatic Triple-Negative Breast Cancer in Second Line gilead.com ↗ |
| 2021-11-10 | Gilead Sciences | Everest Medicines and Gilead Sciences Jointly Announce Phase 2b Study of Sacituzumab Govitecan Conducted in China of Patients With Metastatic Triple-Negative Breast Cancer Meets Primary Overall Response Rate Endpoint gilead.com ↗ |
| 2021-10-28 | Gilead Sciences | Gilead Announces Clinical Trial Collaboration With Merck to Evaluate Trodelvy® (sacituzumab govitecan-hziy) in Combination With KEYTRUDA® (pembrolizumab) in Patients With First-Line Metastatic Triple-Negative Breast Cancer gilead.com ↗ |
| 2021-10-15 | Gilead Sciences | Sacituzumab Govitecan Receives Positive CHMP Opinion as 2L Treatment for Adult Patients With Metastatic Triple-Negative Breast Cancer gilead.com ↗ |
| 2021-09-27 | Gilead Sciences | Gilead Marks Fifth Approval for Trodelvy® in Metastatic Triple-Negative Breast Cancer Under Project Orbis Initiative with Health Canada Authorization gilead.com ↗ |
| 2021-09-16 | Gilead Sciences | Trodelvy® Significantly Improved Quality of Life Over Standard of Care in 2L+ Metastatic Triple-Negative Breast Cancer in Phase 3 ASCENT Study gilead.com ↗ |
| 2021-09-16 | Gilead Sciences | New Data Demonstrate Trodelvy® Survival Benefit in Metastatic Triple-Negative Breast Cancer Patients Regardless of Initial HR/HER2 Status gilead.com ↗ |
| 2021-09-13 | Gilead Sciences | Gilead to Present New Data at ESMO Congress 2021 Reinforcing the Practice-changing Potential of Trodelvy gilead.com ↗ |
| 2021-06-04 | Gilead Sciences | Trodelvy® Demonstrates Superior Outcomes to Standard of Care in Second-Line Treatment of Metastatic Triple-Negative Breast Cancer in Phase 3 ASCENT Study gilead.com ↗ |
| 2021-04-13 | Gilead Sciences | U.S. FDA Grants Accelerated Approval to Trodelvy® for the Treatment of Metastatic Urothelial Cancer gilead.com ↗ |
| 2021-04-07 | Gilead Sciences | FDA Approves Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival gilead.com ↗ |
| 2021-03-25 | Gilead Sciences | European Medicines Agency Validates Marketing Authorization Application for Sacituzumab Govitecan-Hziy for the Treatment of Metastatic Triple-Negative Breast Cancer gilead.com ↗ |
| 2020-12-10 | Gilead Sciences | Gilead Advances Oncology Portfolio With New Data From Phase 3 ASCENT Trial of Trodelvy® in Metastatic Triple Negative Breast Cancer gilead.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 153 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sacituzumab govitecan | “Participants will receive 6 cycles of a standard intravenous or oral chemotherapy regimen or an Antibody-Drug Conjugate (ADC), selected by the investigator from...” NCT07371910 ↗120“Sacituzumab govitecan (SG) significantly improved progression-free survival (PFS) and overall survival (OS) versus chemotherapy in hormone receptor-positive human epidermal...” PMID 39354196 ↗ Oct 2024 “Sacituzumab govitecan (brand name: TRODELVY®) is a cancer treatment, called an antibody-drug conjugate, approved in multiple countries for certain types of breast cancer that...” PMID 41277126 ↗ Nov 2025 “BACKGROUND: Sacituzumab govitecan (SG) is a Trop-2-directed antibody-drug conjugate approved outside Japan for second-line and later metastatic triple-negative breast cancer...” PMID 39302614 ↗ Sep 2024 “antibody-drug conjugates (ADCs) such as sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd) have demonstrated significant activity in HR+/HER2- breast cancer” NCT07162259 ↗ “Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2-expressing cells and is covalently attached to the topoisomerase I inhibitor SN-38.” NCT06065371 ↗ “TREND-02 - a Phase II Exploratory De-escalation Trial of Neoadjuvant Sacituzumab Govitecan Plus Tislelizumab (SG/I) in Early Triple-negative Breast Cancer” NCT07271992 ↗ “Sacituzumab govitecan is a trophoblast cell-surface antigen 2-directed antibody-drug conjugate approved for certain types of breast cancer.” PMID 41073155 ↗ Sep 2025 “ADC therapy includes sacituzumab govitecan or trastuzumab deruxtecan administered intravenously according to standard dosing schedules.” NCT07394218 ↗ “Sacituzumab govitecan (SG) is a novel antibody-drug conjugate, targeting human trophoblast cell-surface antigen 2 (Trop-2).” PMID 36621000 ↗ Jan 2023 “Multimodal ablation combined with pucotenlimab and TPC or sacituzumab govitecan, eribulin,gemcitabine,UTD1” NCT06889610 ↗ “and use of the antibody-drug conjugate sacituzumab govitecan in the later-line metastatic setting.” PMID 33093337 ↗ Feb 2021 “Sacituzumab govitecan (SG) is a Trop-2-directed antibody-drug conjugate with an SN-38 payload” PMID 39186707 ↗ Aug 2024 “For HR+/HER2-zero patients, TROP-2-targeted ADCs such as sacituzumab govitecan are preferred.” NCT07657130 ↗ “Sacituzumab govitecan: 10 mg/kg, ivggt, day 1 and day 8, every 3 weeks;” NCT06793332 ↗ “Sacituzumab govitecan 5 mg/kg every 2 weeks on Day 1 of each cycle（IV）” NCT07077564 ↗ “Capecitabine, Sacituzumab govitecan, Abemaciclib, Venetoclax” NCT05774886 ↗ “the ADC Sacituzumab govitecan (SG), SG plus pembrolizumab” NCT06341478 ↗ “sacituzumab govitecan 10 mg/kg IV (days 1 \& 8, q3w)” NCT06145308 ↗ “sacituzumab govitecan(10mg/kg, d1,8, q3w, ivgtt)” NCT06230055 ↗ “Sacituzumab Govitecan” NCT06667167 ↗ |
| Known as | hRS7-SN38 | “A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer” NCT01631552 ↗ |
| Known as | HRS7-SN38-ANTIBODY-DRUG-CONJUGATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3545262 ↗ |
| Known as | IMMU-132 | “Sacituzumab govitecan (SG), or IMMU-132 is an investigational new drug that utilizes an antibody-drug conjugate (ADC) to target and kill epithelial bladder cancer cells.” NCT05833867 ↗5“A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer” NCT01631552 ↗ “This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132).” NCT05838521 ↗ “* Sacituzumab govitecan (IMMU-132)” NCT04448886 ↗ |
| Known as | Sacituzumab Govitecan-hziy | “Sacituzumab govitecan-hziy (SG), the anti-Trop-2 antibody-drug conjugate, resulted in a significant survival benefit over chemotherapy in patients with metastatic...” PMID 35728046 ↗ May 202229“Sacituzumab govitecan-hziy (SG), the anti-Trop-2 antibody-drug conjugate” PMID 35728046 ↗ May 2022 “Sacituzumab Govitecan-hziy (SG)” NCT05089734 ↗ |
| Known as | SG | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04381832 ↗ |
| Known as | Trodelvy | “This arm of the Strata PATH trial will assess the clinical benefit of Trodelvy® (sacituzumab govitecan) in patients with advanced solid tumors and are Trop2 Treatment Response...” NCT05097599 ↗2“Sacituzumab govitecan is an antibody-drug conjugate, comprising a topoisomerase-I inhibiting camptothecin, SN-38, linked to a humanized antibody targeting trophoblastic...” NCT04826341 ↗ “Sacituzumab govitecan (SG; Trodelvy®) is a trophoblast cell-surface antigen 2 (Trop-2)- directed antibody-drug conjugate” NCT07063212 ↗ |
| Action | Deplete | “delivers SN-38 to kill them” NCT03971409 ↗ |
| Action | Inhibit | “DNA topoisomerase I inhibitor” CHEMBL3545262 ↗ |
| Modality | Other / unclassified | “antibody-drug conjugate sacituzumab govitecan” PMID 33093337 ↗ Feb 2021 |
| Route | Intravenous | “Administered via intravenous (IV) infusion” NCT01631552 ↗ |
| Target | TACSTD2 | “delivering targeted cytotoxic effects to TROP2-overexpressing tumor cells” NCT07492914 ↗ |
| Target | TOP1 | “DNA topoisomerase I inhibitor” CHEMBL3545262 ↗ |