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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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

Key facts

Study ID

NCT06167317

Run by

Gilead Sciences

People needed

278

Starts

2024-01-09

Expected to finish

2028-09-01

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 or cytologically confirmed progressive/advanced selected solid tumor diagnoses harboring defined molecular lesions
• Participants may potentially be required to forgo treatment with approved agent(s) to be able to participate in the study
• Cohort B2:

You may not qualify if…

• 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
• Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started < 14 days prior to planned Cycle 1 Day 1 are not permitted. Hormonal therapy, bisphosphonates, somatostatin analogues, and leuprolide are permitted if started ≥ 14 days prior to planned Cycle 1 Day 1
• Radiotherapy within 2 weeks prior to planned Cycle 1 Day 1 and the radiation is not administered to a target lesion
• Any prior allogeneic tissue/solid organ transplantation, including allogeneic hematopoietic stem cell transplantation. Individuals with a history of autologous hematopoietic stem cell transplantation are also excluded
• Have not recovered (ie, Grade 1 or lower) from AEs due to a previously administered agent
• Prior treatment with approved or experimental prohibited agents as detailed in the protocol.
• Diagnosis of immunodeficiency, either primary or acquired, or requires systemic corticosteroids (> 10 mg of prednisone daily, or equivalent). However, replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
• Have an active second malignancy
• Have known active central nervous system (CNS) metastases
• Individuals with carcinomatous meningitis or primary CNS tumors are excluded regardless of clinical stability
• Meet any of the following criteria for cardiac disease:
• Myocardial infarction or unstable angina pectoris within 6 months of enrollment
• History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication)
• QT interval > 470 msec
• New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction less than 40%

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• NEXT Austin — Austin, Texas, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Dallas — Irving, Texas, United States (enrolling)
• Rambam Health Care Campus — Haifa, Israel (enrolling)
• Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (enrolling)
• Chaim Sheba Medical Center — Tel Litwinsky, Israel (enrolling)

Full record on ClinicalTrials.gov

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