OVERVIEW
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
PROTOCOL 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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Solid Tumor
Gender
N/A
Date
May 2023 - October 2026
Study Type
Interventional
Study Phase
Phase 1
Product
GS-4528, Zimberelimab
Eligibility information
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).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (16)
The University of Washington/FHCC
Seattle, Washington, United States, 98109
University Health Network, Princess Margaret Cancer Centre
Toronto, Canada, M5G 1Z5
Severance Hospital, Yonsei University Health Systems
Seoul, South Korea, 06273
NEXT Oncology-Hospital Quironsalud Barcelona - Unidad de Ensayos Fase 1
Barcelona, Spain, 08023
Hospital Universitari Vall D'Hebron- Oncology Service
Barcelona, Spain, 08035
START MADRID_Hospital Universitario Fundacion Jimenez Diaz - Unidad de Ensayos Fases I
Madrid, Spain, 28040
START MADRID_HM Sanchinarro-CIOCC-Unidad de Ensayos Fases I
Madrid, Spain, 28050
Clinica Universidad de Navarra- Unidad Central de Ensayos Clinicos
Pamplona, Spain, 31008
Chang Gung Memorial Hospital Linkuo Branch of the Chang Gung Medical Foundation
Taoyuan, Taiwan, 333
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
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