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Also known as Sacituzumab Govitecan, Sacituzumab govitecan, Sacituzumab Govitecan (SG)
Sacituzumab Govitecan+ Zimberelimab · 1 trial · 4 indications
clinical evidence of new or progressing nodal or any distant metastatic disease, radical cystectomy, or death due to any cause from date of inclusion to the first documentation of a EFS event. Patients last known to be EFS event-free are censored at the date of last event-free cystoscopy and/or CT scan. Those patients without disease assessment who are still alive will be censored at date of inclusion in the trial
| Arm | Type | Description |
|---|---|---|
| Sacituzumab Govitecan + Zimberelimab | EXPERIMENTAL | patients will be treated with Sacituzumab Govitecan 1,8q21 plus + Zimberelimab q21 for 3 cycles then radiological imaging and TURB will be repeated and patients with Stability of disease or down staging will continue Zimberelimab until disease progression, or unacceptable toxicities or completion of treatment (16 cycles). Patients with progressive disease after 3 cycles of study intervention will be treated as per clinical practice. |
| Name | Type | Description |
|---|---|---|
| Sacituzumab Govitecan + Zimberelimab | DRUG | Sacituzumab Govitecan 7.5 mg/kg IV for 3 cycles Zimberelimab 360 mg IV for 16 cycles Patients will be treated with Sacituzumab Govitecan 1,8q21 plus + Zimberelimab q21 for 3 cycles then radiological imaging and TURB will be repeated and patients with Stability of disease or down staging will continue Zimberelimab until disease progression, or unacceptable toxicities or completion of treatment (16 cycles). Patients with progressive disease after 3 cycles of study intervention will be treated as per clinical practice. |
Inclusion Criteria: * Participant is at least 18 years old of age, at the time of providing informed consent. * The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. E...
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Sacituzumab Govitecan is an investigational antibody-drug conjugate being studied for multiple cancers, including breast cancer, prostate cancer, ovarian carcinoma, bladder cancer, extensive stage small cell lung cancer (ES-SCLC), and urothelial cancer. It is currently in Phase 2 and Phase 3 clinical trials for these oncology indications.
Sacituzumab Govitecan is a monoclonal antibody (mab) drug conjugate. As an antibody-based therapy, it is designed to bind to specific antigens on cancer cells. The drug is being evaluated in biomarker-selected patient populations across several solid tumor types.
Sacituzumab Govitecan is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. Gilead is conducting multiple clinical trials of this investigational agent across various oncology indications.
Sacituzumab Govitecan is in Phase 2 and Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Active trials include Phase 2 studies in breast cancer and extensive stage small cell lung cancer, and a Phase 3 study in triple-negative breast cancer.
Sacituzumab Govitecan is being studied in several trials, including NCT02574455, a completed Phase 3 study in metastatic triple-negative breast cancer; NCT06263543, a recruiting Phase 2 trial in ER+/HER2-low metastatic breast cancer; NCT07178730, a not-yet-recruiting Phase 3 neoadjuvant trial in early triple-negative breast cancer; and NCT07339059, a recruiting Phase 2 trial in extensive stage small cell lung cancer.
Sacituzumab Govitecan is also known as Sacituzumab Govitecan + Zimberelimab, Sacituzumab Govitecan+ Zimberelimab, and Sacituzumab Govitecan (SG). These names refer to the same drug entity being developed by Gilead Sciences for multiple oncology indications.