Study of GS-4528 in Adults With Solid Tumors

NCT05840224 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: GS-US-616-62912022-502070-16
• Study Type: interventional
• Target: 182
• Locations: 6 countries
• Sites: 16

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

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  First dose date up to 90 days post last dose (Up to 24 months)

• Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)

  Day 1 up to 4 weeks

• Maximum Tolerable Dose (MTD) of GS-4528

  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

  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

  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

  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

  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

  Predose on Day 1 and post dose up to 60 day follow-up (Up to 24 months)

Study Arms (3)

Phase 1a: GS-4528 Monotherapy Dose Escalation

EXPERIMENTAL

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

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.

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.

Biological: GS-4528; Drug: Zimberelimab

Interventions

GS-4528 BIOLOGICAL

Administered intravenously

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)

Zimberelimab DRUG

Administered intravenously.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (16)

The University of Washington/FHCC

Seattle, Washington, 98109, United States

Location

The Ottawa Hospital

Ottawa, K1H 8L6, Canada

Location

University Health Network, Princess Margaret Cancer Centre

Toronto, M5G 1Z5, Canada

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Severance Hospital, Yonsei University Health Systems

Seoul, 06273, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

NEXT Oncology-Hospital Quironsalud Barcelona - Unidad de Ensayos Fase 1

Barcelona, 08023, Spain

Location

Hospital Universitari Vall D'Hebron- Oncology Service

Barcelona, 08035, Spain

Location

START MADRID_Hospital Universitario Fundacion Jimenez Diaz - Unidad de Ensayos Fases I

Madrid, 28040, Spain

Location

START MADRID_HM Sanchinarro-CIOCC-Unidad de Ensayos Fases I

Madrid, 28050, Spain

Location

Clinica Universidad de Navarra- Unidad Central de Ensayos Clinicos

Pamplona, 31008, Spain

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 100229, Taiwan

Location

Chang Gung Memorial Hospital Linkuo Branch of the Chang Gung Medical Foundation

Taoyuan District, 333, Taiwan

Location

St Bartholomew's Hospital

London, E1 1FR, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

zimberelimab

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 3, 2023
• Study Start: May 11, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3); GB (2); US (1); CA (2); ES (5); KR (3)