Solid TumorsPhase 1NCT06082960
Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors
A Phase 1 study testing GS-9911 and Zimberelimab in people with Solid Tumors, run by Gilead Sciences at 6 sites in 3 countries.
Trial summary
The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-9911 when given alone or in combination with an anti-programmed cell death protein 1 (PD-1) monoclonal antibody in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- GS-9911 and Zimberelimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 9 Oct 2023to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Parts A, C, and D:
- Participants with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or are ineligible for all treatments known to confer clinical benefit
- Part B:
- Participants whose cancer previously derived clinical benefit from immune checkpoint inhibitors, or who have advanced solid tumor types for which immune checkpoint inhibitors are considered the standard of care and who have received, been intolerant to, or are ineligible for all treatments known to confer clinical benefit
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Evaluable (Part A) or measurable (Parts B, C, and D) disease as per Response Criteria Evaluation in Solid Tumors (RECIST) v1.1 criteria
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- Adequate organ functions
- Tissue requirement:
- Parts A-D: must be willing to provide baseline tumor tissue prior to enrollment
- Part A backfill cohorts: a biopsy should be obtained prior to treatment and on treatment, if safely feasible
- Participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception
Who cannot join
- Positive serum pregnancy test or lactating female
- History of intolerance, hypersensitivity, or treatment discontinuation due to life- threatening immune-related adverse events on prior immunotherapy
- Receipt of the therapies listed below within the specified timeframe prior to planned Cycle 1 Day 1 including: major surgery (< 4 weeks), immunotherapy or biologic therapy (< 28 days), chemotherapy (< 21 days), targeted small molecule therapy (<14 days or 5 half-lives, whichever is sooner), hormonal or other adjunctive therapy (< 14 days), radiation therapy (< 21 days), live vaccine (< 28 days)
- Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation
- Diagnosis of immunodeficiency, or requires systemic corticosteroids (> 10 mg of prednisone daily, or equivalent)
- History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study drug
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- History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, drug-induced pneumonitis, or severe radiation pneumonitis (excluding localized radiation pneumonitis)
- Active second malignancy. Note: individuals with a history of malignancy that have been completed treated, with no evidence of active cancer for 2 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence are allowed to enroll.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Symptomatic cardiovascular disease
- Active serious infection requiring ongoing treatment
- Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV.
- Symptomatic ascites or pleural effusion
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
SCRI Oncology Partners
Nashville, Tennessee, 37203
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, 06520
NEXT Oncology
San Antonio, Texas, 78229
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
Canada1 site
University Health Network, Princess Margaret Cancer Centre
Toronto, M5G
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of GS-9911 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors
The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-9911 when given alone or in combination with an anti-programmed cell death protein 1 (PD-1) monoclonal antibody in participants with advanced solid tumors.
The primary objectives of this study are to:
- Assess the safety and tolerability of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors
- Identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended dose for expansion (RDE) of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors
- Conditions
- Solid Tumors
- Being tested
- GS-9911, Zimberelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-9911Drug
Tablets administered orally
ZimberelimabDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Part A: GS-9911 Monotherapy Dose Escalation | Experimental | Participants will receive escalating doses of GS-9911 monotherapy. Receives: Drug: GS-9911 |
| Part B: GS-9911 Monotherapy Dose Expansion | Experimental | Participants will receive GS-9911 monotherapy at the recommended dose for expansion (RDE) determined in Part A. Receives: Drug: GS-9911 |
| Part C: Dose Escalation: GS-9911 + Anti-PD-1 Monoclonal Antibody | Experimental | Participants will receive escalating doses of GS-9911 in combination with an anti-PD-1 monoclonal antibody (zimberelimab). Receives: Drug: GS-9911; Drug: Zimberelimab |
| Part D: Dose Expansion: GS-9911 + Anti-PD-1 Monoclonal Antibody | Experimental | Participants will receive GS-9911 at RDE determined in Part C in combination with an anti-PD-1 monoclonal antibody (zimberelimab). Receives: Drug: GS-9911; Drug: Zimberelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-emergent Adverse Events
Measured: First dose date up to 90 days post last dose (up to 105 weeks)
Percentage of Participants With Treatment-emergent Serious Adverse Events
Measured: First dose date up to 90 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts
Measured: First dose date up to 3 weeks
Secondary outcomes (4)
Plasma Concentration of GS-9911
Measured: Predose up to end of treatment (up to 105 weeks)
Pharmacokinetic (PK) Parameter: Cmax of GS-9911
Cmax is defined the maximum observed plasma drug concentration.
Measured: Predose up to end of treatment (up to 105 weeks)
PK Parameter: Tmax of GS-9911
Tmax is defined as the time to maximum observed concentration.
Measured: Predose up to end of treatment (up to 105 weeks)
Area Under the Concentration-Time Curve (AUC) of GS-9911
AUC is defined as the area under the concentration versus time curve.
Measured: Predose up to end of treatment (up to 105 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start9 Oct 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 45 participants (estimated)
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
- NCT06082960
- Sponsor's protocol ID
- GS-US-521-6317
- Status last verified
- Apr 2026
- First submitted
- 9 Oct 2023
- Last updated
- 16 Apr 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Tolerability of GS-9911 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06082960
- Acronym / sponsor ID
- GS-US-521-6317
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Oct 2023 (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.
The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-9911 when given alone or in combination with an anti-programmed cell death protein 1 (PD-1) monoclonal antibody in participants with advanced solid tumors.
The primary objectives of this study are to:
- Assess the safety and tolerability of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors
- Identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended dose for expansion (RDE) of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: GS-9911 Monotherapy Dose Escalation | Experimental | Drug: GS-9911Participants will receive escalating doses of GS-9911 monotherapy. |
| Part B: GS-9911 Monotherapy Dose Expansion | Experimental | Drug: GS-9911Participants will receive GS-9911 monotherapy at the recommended dose for expansion (RDE) determined in Part A. |
| Part C: Dose Escalation: GS-9911 + Anti-PD-1 Monoclonal Antibody | Experimental | Drug: GS-9911, Drug: ZimberelimabParticipants will receive escalating doses of GS-9911 in combination with an anti-PD-1 monoclonal antibody (zimberelimab). |
| Part D: Dose Expansion: GS-9911 + Anti-PD-1 Monoclonal Antibody | Experimental | Drug: GS-9911, Drug: ZimberelimabParticipants will receive GS-9911 at RDE determined in Part C in combination with an anti-PD-1 monoclonal antibody (zimberelimab). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Parts A, C, and D:
- Part B:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Evaluable (Part A) or measurable (Parts B, C, and D) disease as per Response Criteria Evaluation in Solid Tumors (RECIST) v1.1 criteria
- Adequate organ functions
Key exclusion criteria (14 listed)
- Positive serum pregnancy test or lactating female
- History of intolerance, hypersensitivity, or treatment discontinuation due to life- threatening immune-related adverse events on prior immunotherapy
- Receipt of the therapies listed below within the specified timeframe prior to planned Cycle 1 Day 1 including: major surgery (< 4 weeks), immunotherapy or biologic therapy (< 28 days), chemotherapy (< 21 days), targeted small molecule therapy (<14 days or 5 half-lives, whichever is sooner), hormonal or other adjunctive therapy (< 14 days), radiation therapy (< 21 days), live vaccine (< 28 days)
- Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation
- Diagnosis of immunodeficiency, or requires systemic corticosteroids (> 10 mg of prednisone daily, or equivalent)
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 |
|---|---|---|
| GS-9911Tablets administered orally | Drug | Part A: GS-9911 Monotherapy Dose Escalation, Part B: GS-9911 Monotherapy Dose Expansion, Part C: Dose Escalation: GS-9911 + Anti-PD-1 Monoclonal Antibody, Part D: Dose Expansion: GS-9911 + Anti-PD-1 Monoclonal Antibody |
| ZimberelimabAdministered intravenously | Drug | Part C: Dose Escalation: GS-9911 + Anti-PD-1 Monoclonal Antibody, Part D: Dose Expansion: GS-9911 + Anti-PD-1 Monoclonal Antibody |
Primary outcome
Percentage of Participants With Treatment-emergent Adverse Events
Time frame: First dose date up to 90 days post last dose (up to 105 weeks)
Percentage of Participants With Treatment-emergent Serious Adverse Events
Time frame: First dose date up to 90 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts
Time frame: First dose date up to 3 weeks
4 secondary outcomes
Plasma Concentration of GS-9911
Time frame: Predose up to end of treatment (up to 105 weeks)
Pharmacokinetic (PK) Parameter: Cmax of GS-9911
Time frame: Predose up to end of treatment (up to 105 weeks)
PK Parameter: Tmax of GS-9911
Time frame: Predose up to end of treatment (up to 105 weeks)
Area Under the Concentration-Time Curve (AUC) of GS-9911
Time frame: Predose up to end of treatment (up to 105 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 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
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-9911 and Zimberelimab in people with Solid Tumors, run by Gilead Sciences at 6 sites in 3 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 11 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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 Participants With Treatment-emergent Adverse Events (time frame: First dose date up to 90 days post last dose (up to 105 weeks)). The study lists 3 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 16 Apr 2026.