Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05006794 | Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies | PHASE1 | ACTIVE NOT_RECRUITING | 145 | — | — | Sep 15, 2021 | Mar 1, 2029 | Jan 7, 2026 | 13 | United States, Israel |
| Arm | Type | Description |
|---|---|---|
| Part A: zamzetoclax Dose-Escalation | EXPERIMENTAL | Patients will receive escalating doses of zamzetoclax to estimate MTD. |
| Part A: zamzetoclax Dose-Expansion | EXPERIMENTAL | Patients will receive ≤ MTD of zamzetoclax. |
| Part B (Cohort B1): Zamzetoclax + docetaxel | EXPERIMENTAL | Patients will receive escalating doses of zamzetoclax in combination with docetaxel. |
| Part B (Cohort B4): zamzetoclax + sacituzumab govitecan-hziy | EXPERIMENTAL | Patients will receive escalating doses of zamzetoclax in combination with sacituzumab govitecan-hziy. |
| Part C (Cohort C1): zamzetoclax + docetaxel | EXPERIMENTAL | Patients will receive ≤ MTD zamzetoclax in combination with docetaxel. |
| Part C (Cohort C4): zamzetoclax + sacituzumab govitecan-hziy | EXPERIMENTAL | Patients will receive ≤ MTD zamzetoclax in combination with sacituzumab govitecan-hziy. |
| Name | Type | Description |
|---|---|---|
| zamzetoclax | DRUG | Tablet(s) administered orally |
| Docetaxel | DRUG | Administered intravenously |
| sacituzumab govitecan-hziy | DRUG | Administered intravenously |
Key Inclusion Criteria: General Inclusion Criteria (all cohorts): * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Measurable disease per RECIST version 1.1 * Adequate hematology, renal and hepatic function * Left ventricular ejection fraction (LVEF) ≥ 50% * Patients with...