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Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies
NCT05006794 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG zamzetoclax
- DRUG sacituzumab govitecan-hziy
Study Locations (13)
Other
- Rambam Health Care Campus — Haifa
- Hadassah Medical Center- Ein Kerem — Jerusalem
- Tel-Aviv Sourasky Medical Center — Tel Aviv
Colorado
- University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) — Aurora
Florida
- Moffitt Cancer Center — Tampa
Michigan
- START Midwest — Grand Rapids
New York
- Montefiore Medial Center - Montefiore Medical Park — The Bronx
North Carolina
- Novant Health Cancer Institute - Elizabeth (Breast Cancer) — Charlotte
Oklahoma
- Stephenson Cancer Center — Oklahoma City
Oregon
- Oregon Health Oregon Health & Sciences University-Knight Cancer Institute — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2021-09-15 |
| Est. Completion | 2029-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05006794
The ClinicalTrials.gov registry entry for NCT05006794 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Solid Malignancies appearing as the primary indexed condition, and to 3 interventions — of which Docetaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05006794 reports 13 study locations spanning 11 distinct geographic areas — top geographies include Other, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05006794 about?
NCT05006794 is a clinical study titled "Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies". 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...
What is the current status of trial NCT05006794?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 145 participants. The study started on 2021-09-15. Estimated completion is 2029-03.
What conditions does trial NCT05006794 study?
This clinical trial studies the following conditions: Solid Malignancies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05006794?
The interventions under investigation include: Docetaxel (DRUG), zamzetoclax (DRUG), sacituzumab govitecan-hziy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05006794?
This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05006794 being conducted?
This trial has 13 study locations across Colorado, Florida, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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