Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors (NCT06167317) | Clinical Trial Compass
RecruitingPhase 1
Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors
United States, Israel278 participantsStarted 2024-01-09
Plain-language summary
The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors.
The primary objectives of this study are to:
* To assess the safety and tolerability of GS-0201 as monotherapy and in combination with SG in participants with selected advanced solid tumors
* To identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of GS-0201 as monotherapy and the MTD and/or the RP2D and dosing schedule of GS-0201 in combination with SG in participants with selected 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.
Inclusion Criteria:
* Able to understand and give written informed consent.
* Assigned female or male at birth, 18 years of age or older, and meet the age of majority/adulthood per local regulations.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria by investigator assessment.
* Organ function requirements:
* Adequate hematologic function
* Adequate hepatic function
* Creatinine clearance
* Coagulation
* Tissue requirement:
* Parts A, B, C, and D:
* Pre-treatment tumor tissue is required.
* Parts A and C backfill biopsy cohorts:
* Individuals must agree to fresh pre- and on-treatment biopsies.
* Individuals assigned male at birth and individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
* Willing and able to comply with the requirements and restrictions in this protocol
* Part A (GS-0201 Monotherapy Dose Escalation) Inclusion Criteria:
* Histologically/cytologically confirmed progressive/advanced solid tumors with selected molecular lesions.
* Individuals must have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy
* Part B (Dose Expansion) Inclusion Criteria:
* Disease documented as:
* Cohort B1:
* Histologically …
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
The Number of Participants with Dose Limiting Toxicities (DLTs) During Dose Escalation
Timeframe: First dose up to 30 days post last dose (Up to approximately 109 weeks).
2
The Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: First dose up to 30 days post last dose (Up to approximately 109 weeks).
3
The Incidence of Laboratory Abnormalities
Timeframe: First dose up to 30 days post last dose (Up to approximately 109 weeks).