Solid MalignanciesPhase 1NCT05006794
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies
A Phase 1 study testing zamzetoclax, Docetaxel and sacituzumab govitecan-hziy in people with Solid Malignancies, run by Gilead Sciences at 13 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Malignancies
- What is being tested?
- zamzetoclax, Docetaxel and sacituzumab govitecan-hziy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 15 Sep 2021to 16 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 brain metastases may be enrolled only if treated, nonprogressive, asymptomatic and not taking high dose steroids for at least 4 weeks prior to Cycle 1 Day 1 (C1D1)
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- Individuals of childbearing potential who engage in heterosexual intercourse must agree to use method(s) of contraception, per protocol.
- Tissue criteria: must provide sufficient, and adequate tumor tissue sample or agree to have a biopsy taken.
- Part A Specific Inclusion Criteria: zamzetoclax as monotherapy
- Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumor for which no standard therapy is available, standard therapy has failed, or for whom standard-of-care therapy is contraindicated.
- Cohorts B1 and C1 Specific Inclusion Criteria:
- Histologically or cytologically confirmed unresectable metastatic or locally advanced disease following treatment for metastatic disease including an immune checkpoint inhibitor and a platinum-containing chemotherapy
- Patients with actionable genomic alterations must have also received treatment with at least 1 approved therapy appropriate to the genomic alteration unless unavailable or contraindicated
- Cohorts B4 and C4 Specific Inclusion Criteria:
- Histologically or cytologically confirmed disease based on the most recent analyzed biopsy metastatic disease that is refractory to or relapsed after at least 2 prior standard-of-care chemotherapy regimens, one of which was a taxane (unless contraindicated).
Who cannot join
- Prior systemic anti-cancer therapy must meet wash-out criteria outlined in protocol
- Treatment with any high dose systemic corticosteroids or nonsystemic radiotherapy within 2 weeks of the first dose of zamzetoclax (low dose corticosteroids permitted).
- Women who are pregnant or lactating
- Patients with active ≥ Grade 2 nausea or vomiting, and/or signs of intestinal obstruction
- Known active or chronic hepatitis B or C infection or HIV infection/ HIV positive
- Known history of clinically significant cardiovascular disease or heart failure.
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- Known history of clinically significant active chronic obstructive pulmonary disease or other moderate to severe chronic respiratory illness present within 6 months prior to C1D1
- Known history of other clinically significant pulmonary disease or evidence of active pneumonitis
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- History of clinically significant bleeding, intestinal obstruction, or gastrointestinal (GI) perforation within 6 months prior to C1D1
- Infection requiring intravenous anti-infective use within 2 weeks prior to C1D1
- Active or history of autoimmune disease or immune deficiency
- History of uncured coexisting cancer, not including uncured basal cell carcinoma, cervical cancer in situ, or superficial bladder cancer.
- Cohort A Specific Exclusion Criteria: zamzetoclax as monotherapy:
- Known heart failure or elevated cardiac biomarkers
- Cohorts B1 and C1 Specific Exclusion Criteria:
- Known hypersensitivity to excipients in study treatments.
- Cohorts B4 and C4 Specific Exclusion Criteria:
- Prior treatment with sacituzumab govitecan-hziy or a topoisomerase 1 inhibitor or agents targeting Trop-2.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045
Novant Health Cancer Institute - Elizabeth (Breast Cancer)
Charlotte, North Carolina, 28204
START Midwest
Grand Rapids, Michigan, 49546
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Oregon Health Oregon Health & Sciences University-Knight Cancer Institute
Portland, Oregon, 97239
START San Antonio
San Antonio, Texas, 78229
Moffitt Cancer Center
Tampa, Florida, 33612
Montefiore Medial Center - Montefiore Medical Park
The Bronx, New York, 10467
START Mountain Region
West Valley City, Utah, 84119
Israel3 sites
Rambam Health Care Campus
Haifa, 31096
Hadassah Medical Center- Ein Kerem
Jerusalem, 91120
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906
About this study
Official title: A Phase 1a/b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Subjects 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 of zamzetoclax, and characterize the safety and tolerability of zamzetoclax as monotherapy and in combination with anti-cancer therapies.
- Conditions
- Solid Malignancies
- Being tested
- zamzetoclax, Docetaxel, sacituzumab govitecan-hziy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zamzetoclaxDrug
Also called GS-9716
Tablet(s) administered orally
DocetaxelDrug
Administered intravenously
sacituzumab govitecan-hziyDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Part A: zamzetoclax Dose-Escalation | Experimental | Patients will receive escalating doses of zamzetoclax to estimate MTD. Receives: Drug: zamzetoclax |
| Part A: zamzetoclax Dose-Expansion | Experimental | Patients will receive ≤ MTD of zamzetoclax. Receives: Drug: zamzetoclax |
| Part B (Cohort B1): Zamzetoclax + docetaxel | Experimental | Patients will receive escalating doses of zamzetoclax in combination with docetaxel. Receives: Drug: zamzetoclax; Drug: Docetaxel |
| Part B (Cohort B4): zamzetoclax + sacituzumab govitecan-hziy | Experimental | Patients will receive escalating doses of zamzetoclax in combination with sacituzumab govitecan-hziy. Receives: Drug: zamzetoclax; Drug: sacituzumab govitecan-hziy |
| Part C (Cohort C1): zamzetoclax + docetaxel | Experimental | Patients will receive ≤ MTD zamzetoclax in combination with docetaxel. Receives: Drug: zamzetoclax; Drug: Docetaxel |
| Part C (Cohort C4): zamzetoclax + sacituzumab govitecan-hziy | Experimental | Patients will receive ≤ MTD zamzetoclax in combination with sacituzumab govitecan-hziy. Receives: Drug: zamzetoclax; Drug: sacituzumab govitecan-hziy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Experiencing Dose-Limiting Toxicities (DLTs)
Measured: 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
Measured: First dose date up to last dose date (Maximum: 105 weeks) plus 30 days
Secondary outcomes (8)
Maximum Observed Concentration (Cmax) for Zamzetoclax
Measured: Approximately 105 Weeks
Time to Maximum Observed Concentration (Tmax) for Zamzetoclax
Measured: Approximately 105 Weeks
Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) for Zamzetoclax
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first documentation of CR or PR to PD or death, whichever occurs first (up to 37 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start15 Sep 2021
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Why it stopped: Sponsor decision to terminate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid MalignanciesStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006794
- Sponsor's protocol ID
- GS-US-467-5643
- Status last verified
- Jul 2026
- First submitted
- 9 Aug 2021
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Subjects With Solid Malignancies
- ClinicalTrials.gov ID
- NCT05006794
- Acronym / sponsor ID
- GS-US-467-5643
- Conditions
- Solid Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to terminate
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: zamzetoclax Dose-Escalation | Experimental | Drug: zamzetoclaxPatients will receive escalating doses of zamzetoclax to estimate MTD. |
| Part A: zamzetoclax Dose-Expansion | Experimental | Drug: zamzetoclaxPatients will receive ≤ MTD of zamzetoclax. |
| Part B (Cohort B1): Zamzetoclax + docetaxel | Experimental | Drug: zamzetoclax, Drug: DocetaxelPatients will receive escalating doses of zamzetoclax in combination with docetaxel. |
| Part B (Cohort B4): zamzetoclax + sacituzumab govitecan-hziy | Experimental | Drug: zamzetoclax, Drug: sacituzumab govitecan-hziyPatients will receive escalating doses of zamzetoclax in combination with sacituzumab govitecan-hziy. |
| Part C (Cohort C1): zamzetoclax + docetaxel | Experimental | Drug: zamzetoclax, Drug: DocetaxelPatients will receive ≤ MTD zamzetoclax in combination with docetaxel. |
| Part C (Cohort C4): zamzetoclax + sacituzumab govitecan-hziy | Experimental | Drug: zamzetoclax, Drug: sacituzumab govitecan-hziyPatients will receive ≤ MTD zamzetoclax in combination with sacituzumab govitecan-hziy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 brain metastases may be enrolled only if treated, nonprogressive, asymptomatic and not taking high dose steroids for at least 4 weeks prior to Cycle 1 Day 1 (C1D1)
Key exclusion criteria (20 listed)
- Prior systemic anti-cancer therapy must meet wash-out criteria outlined in protocol
- Treatment with any high dose systemic corticosteroids or nonsystemic radiotherapy within 2 weeks of the first dose of zamzetoclax (low dose corticosteroids permitted).
- Women who are pregnant or lactating
- Patients with active ≥ Grade 2 nausea or vomiting, and/or signs of intestinal obstruction
- Known active or chronic hepatitis B or C infection or HIV infection/ HIV positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zamzetoclaxAlso: GS-9716Tablet(s) administered orally | Drug | Part A: zamzetoclax Dose-Escalation, Part A: zamzetoclax Dose-Expansion, Part B (Cohort B1): Zamzetoclax + docetaxel, Part B (Cohort B4): zamzetoclax + sacituzumab govitecan-hziy, Part C (Cohort C1): zamzetoclax + docetaxel, Part C (Cohort C4): zamzetoclax + sacituzumab govitecan-hziy |
| DocetaxelAdministered intravenously | Drug | Part B (Cohort B1): Zamzetoclax + docetaxel, Part C (Cohort C1): zamzetoclax + docetaxel |
| sacituzumab govitecan-hziyAdministered intravenously | Drug | Part B (Cohort B4): zamzetoclax + sacituzumab govitecan-hziy, Part C (Cohort C4): zamzetoclax + sacituzumab govitecan-hziy |
Primary outcome
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
8 secondary outcomes
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)
Time frame: Up to 105 weeks
Parts B and C: Disease Control Rate (DCR)
Time frame: Up to 105 weeks
Parts B and C: Progression-Free Survival (PFS)
Time frame: First dose date to PD or death, whichever occurs first (up to 39 months)
Parts B and C: Time to Response (TTR)
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)
Time frame: From first documentation of CR or PR to PD or death, whichever occurs first (up to 37 months)
Results and safety
The study was stopped early (reason given: Sponsor decision to terminate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing zamzetoclax, Docetaxel and sacituzumab govitecan-hziy in people with Solid Malignancies, run by Gilead Sciences at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision to terminate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Experiencing Dose-Limiting Toxicities (DLTs) (time frame: First dose date up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.