Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors (NCT06167317)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (34 items) and avoid the listed exclusions (41 items).
Location: Dana-Farber Cancer Institute — Boston, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Pregnant or lactating females
- Known hypersensitivity to any of the study drugs, its metabolites, or formulation excipients
- Requirement for ongoing therapy with or use of any prohibited medications described in the protocol
- Individuals with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with findings suggestive of MDS/AML
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of GS-0201
- The therapies listed below within the specified timeframe:
- Major surgery (excluding minor procedures, eg, placement of vascular access, gastrointestinal/biliary stent, biopsy) \< 4 weeks prior to planned Cycle 1 Day 1
- Immunotherapy or biologic therapy \< 21 days prior to planned Cycle 1 Day 1
- Chemotherapy \< 14 days prior to planned Cycle 1 Day 1, or \< 42 days for mitomycin or nitrosoureas
- Targeted small molecule therapy \< 14 days prior to planned Cycle 1 Day 1
- Receipt of experimental therapy within 21 days or 5 experimental treatment half-lives (whichever is longer) prior to planned Cycle 1 Day 1
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (8 Sites)
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Memorial Sloan Kettering Cancer Center — New York, New York
- NEXT Austin — Austin, Texas
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- NEXT Dallas — Irving, Texas
- Rambam Health Care Campus — Haifa,
- Tel Aviv Sourasky Medical Center — Tel Aviv,
- Chaim Sheba Medical Center — Tel Litwinsky,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.