A Phase 1 interventional study of zamzetoclax and Docetaxel in Solid Malignancies, sponsored by Gilead Sciences. Terminated at 13 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Gilead Sciences · Phase 1, Interventional, and Treatment
This is a Phase I open-label, multi-center study of zamzetoclax (formerly GS-9716) tested either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies. Primary objectives are to define the maximum tolerated dose (MTD) or maximum administered dose of zamzetoclax, and characterize the safety and tolerability of zamzetoclax as monotherapy and in combination with anti-cancer therapies.
Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
General Inclusion Criteria (all cohorts):
Part A Specific Inclusion Criteria: zamzetoclax as monotherapy
Cohorts B1 and C1 Specific Inclusion Criteria:
Cohorts B4 and C4 Specific Inclusion Criteria:
Key Exclusion Criteria:
Cohort A Specific Exclusion Criteria: zamzetoclax as monotherapy:
Cohorts B1 and C1 Specific Exclusion Criteria:
Cohorts B4 and C4 Specific Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Patients will receive escalating doses of zamzetoclax to estimate MTD.
Drug: zamzetoclax
Patients will receive ≤ MTD of zamzetoclax.
Drug: zamzetoclax
Patients will receive escalating doses of zamzetoclax in combination with docetaxel.
Drug: zamzetoclax · Drug: Docetaxel
Patients will receive escalating doses of zamzetoclax in combination with sacituzumab govitecan-hziy.
Drug: zamzetoclax · Drug: sacituzumab govitecan-hziy
Patients will receive ≤ MTD zamzetoclax in combination with docetaxel.
Drug: zamzetoclax · Drug: Docetaxel
Patients will receive ≤ MTD zamzetoclax in combination with sacituzumab govitecan-hziy.
Drug: zamzetoclax · Drug: sacituzumab govitecan-hziy
Tablet(s) administered orally
Also known as: GS-9716
Administered intravenously
Administered intravenously
Percentage of Patients Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: First dose date up to 28 days
Percentage of Patients Experiencing Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0
Time frame: First dose date up to last dose date (Maximum: 105 weeks) plus 30 days
Maximum Observed Concentration (Cmax) for Zamzetoclax
Time frame: Approximately 105 Weeks
Time to Maximum Observed Concentration (Tmax) for Zamzetoclax
Time frame: Approximately 105 Weeks
Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) for Zamzetoclax
Time frame: Approximately 105 Weeks
Parts B and C: Objective Response Rate (ORR)
ORR is defined as the percentage of patients who achieve a confirmed complete response (CR) or confirmed partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to 105 weeks
Parts B and C: Disease Control Rate (DCR)
DCR is defined as the percentage of patients who achieve a CR, PR, or stable disease (SD) as assessed by RECIST version 1.1.
Time frame: Up to 105 weeks
Parts B and C: Progression-Free Survival (PFS)
PFS is defined as the interval from the first dose of zamzetoclax to the earlier of the first documentation of definitive progressive disease (PD) or death from any cause.
Time frame: First dose date to PD or death, whichever occurs first (up to 39 months)
Parts B and C: Time to Response (TTR)
TTR is defined as the time from first dose of zamzetoclax to the first documentation of CR or PR.
Time frame: First dose date to the first documentation of CR or PR (up to 105 weeks)
Parts B and C: Duration of Response (DOR)
DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause.
Time frame: From first documentation of CR or PR to PD or death, whichever occurs first (up to 37 months)
Plan to share: No
This study is terminated, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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