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Testing GS-4528 for adults with solid tumors

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

PHASE1 · Gilead Sciences · NCT05840224

This study is testing a new treatment called GS-4528, alone and with another drug, to see if it is safe and effective for adults with advanced solid tumors who have run out of other options.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment182 (estimated)
Ages18 Years and up
SexAll
SponsorGilead Sciences (industry)
Drugs / interventionschemotherapy, immunotherapy, radiation, prednisone
Locations16 sites (Seattle, Washington and 15 other locations)
Trial IDNCT05840224 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety and tolerability of GS-4528, both alone and in combination with an anti-PD-1 monoclonal antibody, in adults with advanced solid tumors. The study will assess the maximum tolerated dose and the recommended Phase 2 dose for further development. Participants will be closely monitored for any adverse effects and overall response to the treatment. The study is designed for individuals who have exhausted other treatment options or are intolerant to them.

Who should consider this trial

Good fit: Ideal candidates include adults with histologically or cytologically confirmed advanced solid tumors who have not benefited from existing therapies.

Not a fit: Patients with early-stage tumors or those who have not yet received standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: Other studies have shown promise with similar approaches targeting solid tumors, indicating potential for success in this area.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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.
* 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.

Key Exclusion Criteria:

* 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.
* 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.

Where this trial is running

Seattle, Washington and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Solid Tumor

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.