Solid TumorPhase 1NCT05840224
Study of GS-4528 in Adults With Solid Tumors
A Phase 1 study testing GS-4528 and Zimberelimab in people with Solid Tumor, run by Gilead Sciences at 16 sites in 6 countries.
Trial summary
The goals of this clinical study are to identify if GS-4528 alone or in combination with anti-programmed cell death protein 1 (PD-1) (Anti-PD-1) Monoclonal Antibody is safe and tolerable in people with solid tumors and to identify the recommended dose of GS-4528 for further development that is safe to give to people… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- GS-4528 and Zimberelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 11 May 2023to Oct 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
- Documented disease:
- Phase 1a dose escalation and backfill cohorts; Phase 1b dose escalation: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy.
- Phase 1a dose expansion: Individuals with histologically or cytologically confirmed select indications who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy.
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
- Adequate organ function.
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- Individuals of childbearing potential who engage in heterosexual intercourse must agree to use method(s) of contraception.
- Tissue requirements:
- Phase 1a dose escalation, Phase 1a dose expansion, and Phase 1b dose escalation: Must provide pre-treatment adequate tumor tissue sample prior to enrolment.
- Phase 1a backfill cohorts: Individuals must have fresh pre-treatment and on-treatment biopsy for biomarker analysis.
- Life expectancy ≥ 3 months.
Who cannot join
- Positive serum pregnancy test or lactating female.
- Prohibited concurrent anticancer therapy listed in the protocol.
- Any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study including: major surgery (<28 days), immunotherapy or biologic therapy (< 28 days), chemotherapy (< 21 days), targeted small molecule therapy (< 14 days or < 5 half-lives whichever is shorter), hormonal therapy or other adjunctive therapy (< 14 days) or radiotherapy (< 21 days).
- Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation.
- Diagnosis of immunodeficiency, either primary or acquired, or systemic steroid requirement of > 10 mg of prednisone or equivalent.
- History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy.
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- History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study treatment.
- Concurrent active second malignancy. Note: Individuals with a history of malignancy that have been completely treated, with no evidence of active cancer for 2 years prior to enrollment, or participants with surgically cured tumors with low risk of recurrence are allowed to enroll.
- Have known active central nervous system (CNS) metastases and/ or carcinomatous meningitis.
- Significant cardiovascular disease.
- Have active serious infection requiring antibiotics.
- Have active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis).
- Symptomatic ascites or pleural effusion.
- Live vaccines within 28 days of initiation of investigational product(s).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
Spain5 sites
NEXT Oncology-Hospital Quironsalud Barcelona - Unidad de Ensayos Fase 1
Barcelona, 08023
Hospital Universitari Vall D'Hebron- Oncology Service
Barcelona, 08035
START MADRID_Hospital Universitario Fundacion Jimenez Diaz - Unidad de Ensayos Fases I
Madrid, 28040
START MADRID_HM Sanchinarro-CIOCC-Unidad de Ensayos Fases I
Madrid, 28050
Clinica Universidad de Navarra- Unidad Central de Ensayos Clinicos
Pamplona, 31008
South Korea3 sites
Asan Medical Center
Seoul, 05505
Severance Hospital, Yonsei University Health Systems
Seoul, 06273
Samsung Medical Center
Seoul, 06351
Taiwan3 sites
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 100229
Chang Gung Memorial Hospital Linkuo Branch of the Chang Gung Medical Foundation
Taoyuan, 333
Canada2 sites
The Ottawa Hospital
Ottawa, K1H 8L6
University Health Network, Princess Margaret Cancer Centre
Toronto, M5G 1Z5
United Kingdom2 sites
St Bartholomew's Hospital
London, E1 1FR
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
United States1 site
The University of Washington/FHCC
Seattle, Washington, 98109
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of GS-4528 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors
The goals of this clinical study are to identify if GS-4528 alone or in combination with anti-programmed cell death protein 1 (PD-1) (Anti-PD-1) Monoclonal Antibody is safe and tolerable in people with solid tumors and to identify the recommended dose of GS-4528 for further development that is safe to give to people alone or in combination with Anti-PD-1 Monoclonal Antibody.
The primary objectives of this study are:
- To assess the safety and tolerability of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors.
- To identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors.
- Conditions
- Solid Tumor
- Being tested
- GS-4528, Zimberelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-4528Biological
Administered intravenously
ZimberelimabDrug
Administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: GS-4528 Monotherapy Dose Escalation | Experimental | Participants will receive escalating doses of GS-4528 monotherapy to determine the maximum tolerated dose. Receives: Biological: GS-4528 |
| Phase 1a: GS-4528 Monotherapy Dose Expansion | Experimental | Participants will receive GS-4528 monotherapy at the dose determined in the escalation phase. Receives: Biological: GS-4528 |
| Phase 1b:Dose Escalation of GS-4528 in Combination With Anti-PD-1 Monoclonal Antibody (zimberelimab) | Experimental | Participants will receive escalating doses of GS-4528 in combination with anti-PD1 monoclonal antibody (zimberelimab) to determine the maximum tolerated dose of GS-4528 as a combination therapy. Receives: Biological: GS-4528; Drug: Zimberelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: First dose date up to 90 days post last dose (Up to 24 months)
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
Measured: Day 1 up to 4 weeks
Maximum Tolerable Dose (MTD) of GS-4528
Measured: Day 1 up to 4 weeks
Secondary outcomes (5)
Pharmacokinetic (PK) parameter: Cmax of GS-4528 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody
Cmax is defined as the maximum observed concentration of drug.
Measured: Predose on Day 1 and post dose up to end of treatment (EOT, Up to 24 months)
PK parameter: Cmin of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody
Cmin is defined as the minimum observed concentration of drug.
Measured: Predose on Day 1 and post dose up to EOT (Up to 24 months)
PK parameter: AUC of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody
AUC is defined as the area under the concentration versus time curve.
Measured: Predose on Day 1 and post dose up to EOT (Up to 24 months)
Serum Concentrations of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody
Measured: Predose on Day 1 and post dose up to EOT (Up to 24 months)
Percentage of Participants who Develop Antidrug Antibody (ADA) Against GS-4528
Measured: Predose on Day 1 and post dose up to 60 day follow-up (Up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start11 May 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 182 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
- NCT05840224
- Sponsor's protocol ID
- GS-US-616-6291
- Other IDs
- 2022-502070-16
- Status last verified
- Jul 2026
- First submitted
- 21 Apr 2023
- Last updated
- 27 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 27 Jul 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-4528 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05840224
- Acronym / sponsor ID
- GS-US-616-6291
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 11 May 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 3 May 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 goals of this clinical study are to identify if GS-4528 alone or in combination with anti-programmed cell death protein 1 (PD-1) (Anti-PD-1) Monoclonal Antibody is safe and tolerable in people with solid tumors and to identify the recommended dose of GS-4528 for further development that is safe to give to people alone or in combination with Anti-PD-1 Monoclonal Antibody.
The primary objectives of this study are:
- To assess the safety and tolerability of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors.
- To identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of GS-4528 as monotherapy and in combination with 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: GS-4528 Monotherapy Dose Escalation | Experimental | Biological: GS-4528Participants will receive escalating doses of GS-4528 monotherapy to determine the maximum tolerated dose. |
| Phase 1a: GS-4528 Monotherapy Dose Expansion | Experimental | Biological: GS-4528Participants will receive GS-4528 monotherapy at the dose determined in the escalation phase. |
| Phase 1b:Dose Escalation of GS-4528 in Combination With Anti-PD-1 Monoclonal Antibody (zimberelimab) | Experimental | Biological: GS-4528, Drug: ZimberelimabParticipants will receive escalating doses of GS-4528 in combination with anti-PD1 monoclonal antibody (zimberelimab) to determine the maximum tolerated dose of GS-4528 as a combination therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Documented disease:
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
- Adequate organ function.
- Individuals of childbearing potential who engage in heterosexual intercourse must agree to use method(s) of contraception.
Key exclusion criteria (16 listed)
- Positive serum pregnancy test or lactating female.
- Prohibited concurrent anticancer therapy listed in the protocol.
- Any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study including: major surgery (<28 days), immunotherapy or biologic therapy (< 28 days), chemotherapy (< 21 days), targeted small molecule therapy (< 14 days or < 5 half-lives whichever is shorter), hormonal therapy or other adjunctive therapy (< 14 days) or radiotherapy (< 21 days).
- Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation.
- Diagnosis of immunodeficiency, either primary or acquired, or systemic steroid requirement of > 10 mg of prednisone 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-4528Administered intravenously | Biological | Phase 1a: GS-4528 Monotherapy Dose Escalation, Phase 1a: GS-4528 Monotherapy Dose Expansion, Phase 1b:Dose Escalation of GS-4528 in Combination With Anti-PD-1 Monoclonal Antibody (zimberelimab) |
| ZimberelimabAdministered intravenously. | Drug | Phase 1b:Dose Escalation of GS-4528 in Combination With Anti-PD-1 Monoclonal Antibody (zimberelimab) |
Primary outcome
Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: First dose date up to 90 days post last dose (Up to 24 months)
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
Time frame: Day 1 up to 4 weeks
Maximum Tolerable Dose (MTD) of GS-4528
Time frame: Day 1 up to 4 weeks
5 secondary outcomes
Pharmacokinetic (PK) parameter: Cmax of GS-4528 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody
Time frame: Predose on Day 1 and post dose up to end of treatment (EOT, Up to 24 months)
PK parameter: Cmin of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody
Time frame: Predose on Day 1 and post dose up to EOT (Up to 24 months)
PK parameter: AUC of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody
Time frame: Predose on Day 1 and post dose up to EOT (Up to 24 months)
Serum Concentrations of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody
Time frame: Predose on Day 1 and post dose up to EOT (Up to 24 months)
Percentage of Participants who Develop Antidrug Antibody (ADA) Against GS-4528
Time frame: Predose on Day 1 and post dose up to 60 day follow-up (Up to 24 months)
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 27 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
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-4528 and Zimberelimab in people with Solid Tumor, run by Gilead Sciences at 16 sites in 6 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 16 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 27 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 16 sites in Spain, South Korea, Taiwan, Canada, United Kingdom and 1 more country. 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 Experiencing Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: First dose date up to 90 days post last dose (Up to 24 months)). 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 27 Jul 2026.