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Clinical Trials in the USA / NCT05840224
Active, not recruiting Phase 1

Study of GS-4528 in Adults With Solid Tumors

NCT05840224 · tracked via the Priya Life Science USA tracker
Sponsor
Gilead Sciences
Phase
Phase 1
Started
2023-05-11
Last updated
2026-07-27

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

GS-4528Zimberelimab

GS-4528: Administered intravenously

Zimberelimab: Administered intravenously.

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
The University of Washington/FHCC Seattle Washington
The Ottawa Hospital Ottawa Canada
University Health Network, Princess Margaret Cancer Centre Toronto Canada
Asan Medical Center Seoul South Korea
Severance Hospital, Yonsei University Health Systems Seoul South Korea
Samsung Medical Center Seoul South Korea
NEXT Oncology-Hospital Quironsalud Barcelona - Unidad de Ensayos Fase 1 Barcelona Spain
Hospital Universitari Vall D'Hebron- Oncology Service Barcelona Spain
START MADRID_Hospital Universitario Fundacion Jimenez Diaz - Unidad de Ensayos Fases I Madrid Spain
START MADRID_HM Sanchinarro-CIOCC-Unidad de Ensayos Fases I Madrid Spain
Clinica Universidad de Navarra- Unidad Central de Ensayos Clinicos Pamplona Spain
Taichung Veterans General Hospital Taichung Taiwan
National Taiwan University Hospital Taipei Taiwan
Chang Gung Memorial Hospital Linkuo Branch of the Chang Gung Medical Foundation Taoyuan Taiwan
St Bartholomew's Hospital London United Kingdom
The Royal Marsden NHS Foundation Trust Sutton United Kingdom

More Gilead Sciences trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05840224 on ClinicalTrials.gov ↗ ← All trials in the USA