Study of GS-4528 in Adults With Solid Tumors

NCT ID: NCT05840224

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-11
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1a: GS-4528 Monotherapy Dose Escalation

Participants will receive escalating doses of GS-4528 monotherapy to determine the maximum tolerated dose.

Group Type: EXPERIMENTAL

GS-4528

Intervention Type: BIOLOGICAL

Administered intravenously

Phase 1a: GS-4528 Monotherapy Dose Expansion

Participants will receive GS-4528 monotherapy at the dose determined in the escalation phase.

Group Type: EXPERIMENTAL

GS-4528

Intervention Type: BIOLOGICAL

Administered intravenously

Phase 1b:Dose Escalation of GS-4528 in Combination With Anti-PD-1 Monoclonal Antibody (zimberelimab)

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.

Group Type: EXPERIMENTAL

GS-4528

Intervention Type: BIOLOGICAL

Administered intravenously

Zimberelimab

Intervention Type: DRUG

Administered intravenously.

Interventions

GS-4528

Administered intravenously

Intervention Type: BIOLOGICAL

Zimberelimab

Administered intravenously.

Intervention Type: DRUG

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

The University of Washington/FHCC

Seattle, Washington, United States

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 District, , Taiwan

St Bartholomew's Hospital

London, , United Kingdom

The Royal Marsden NHS Foundation Trust

Sutton, , United Kingdom

Countries

United States; Canada; South Korea; Spain; Taiwan; United Kingdom

Related Links

https://www.gileadclinicaltrials.com/study?nctid=NCT05840224

Gilead Clinical Trials Website

Other Identifiers

2022-502070-16

Identifier Type: OTHER

Identifier Source: secondary_id

GS-US-616-6291

Identifier Type: -

Identifier Source: org_study_id