RecruitingPhase 1NCT06167317

Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-0201 as Monotherapy and in Combination in Adults With Advanced Solid Tumors


Sponsor

Gilead Sciences

Enrollment

278 participants

Start Date

Jan 9, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called GS-0201 and a drug called Sacituzumab Govitecan for people with advanced solid tumors. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGS-0201

Pill administered orally

DRUGSacituzumab Govitecan

Administered intravenously


Locations(8)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

NEXT Austin

Austin, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Dallas

Irving, Texas, United States

Rambam Health Care Campus

Haifa, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Chaim Sheba Medical Center

Tel Litwinsky, Israel

View Full Details on ClinicalTrials.gov

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NCT06167317


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