Study of GS-4528 in Adults With Solid Tumors (NCT05840224) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of GS-4528 in Adults With Solid Tumors
United States, Canada, South Korea182 participantsStarted 2023-05-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 prot…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding the maximum tolerable dose of GS-4528, what does that mean for what's currently known about how safe and effective it might be for my type of solid tumor?
2The trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — is there any chance I could still be considered, or are there similar early-phase trials I should be looking into instead?
3Because the primary goal of this study is to measure serious adverse events and dose-limiting toxicities, what kinds of side effects are researchers watching most closely with GS-4528, and how would those be managed if they happened to me?
4Would pursuing a standard treatment option first make more sense before considering an experimental drug at this stage of research, and how would participating in a Phase 1 trial affect my ability to try other therapies later?
5Given that my specific type of solid tumor may be different from others enrolled in this trial, how would you assess whether GS-4528 is even a relevant treatment avenue worth pursuing for my diagnosis?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: First dose date up to 90 days post last dose (Up to 24 months)
2
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)