Study of GS-0201 for Advanced Solid Tumors
This study is looking at a new drug called GS-0201, given as a pill, either by itself or with another drug called sacituzumab govitecan (given through a vein). It's for people with advanced solid tumors. The main goal is to find out how safe these treatments are and what doses work best. Researchers will be carefully watching for any side effects or problems with blood tests. You might be able to join if you are 18 or older, can understand and sign consent forms, and have advanced solid tumors that can be measured. The study is currently unclear on its recruitment status and plans to enroll up to 278 participants.
- Study design
- This is a study to learn about the safety and dosing of GS-0201, alone or in combination. It plans to include up to 278 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for side effects and laboratory changes from the first dose up to 30 days after the last dose, for approximately 109 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06167317
Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentGilead Sciences
~278 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:GS-0201Sacituzumab Govitecan
At a glance
Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The Number of Participants with Dose Limiting Toxicities (DLTs) During Dose Escalation
Measured over First dose up to 30 days post last dose (Up to approximately 109 weeks).
+2 more outcomes measured
Conditions
Where it's being run
8 sites across 4 statesTexas3
Israel3
Massachusetts1
New York1
Study leadership
- Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
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:
Histologically or cytologically confirmed progressive/advanced solid tumor diagnoses harboring defined molecular lesions not included in Cohort B1
Histologically or cytologically confirmed unresectable locally advanced/metastatic selected solid tumors
Disease documented as:
Cohort D1:
Histologically or cytologically confirmed unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC)
Cohort D2:
Recurrent/persistent endometrial cancer
Exclusion
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%
Meet any of the following infectious criteria:
Have active serious infection requiring antimicrobials
Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or HIV. In individuals with a history of HBV or HCV, individuals with detectable viral loads will be excluded
Individuals who test positive for hepatitis B surface antigen. Individuals who test positive for hepatitis B core antibody are eligible with a negative HBV DNA by quantitative Polymerase chain reaction (PCR)
Individuals who test positive for HCV antibody. Individuals who test positive for HCV antibody are eligible with a negative HCV RNA by quantitative PCR
Individuals who test positive for HIV antibody
History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, or radiation pneumonitis requiring steroids
Symptomatic ascites or pleural effusion
Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations
Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the individuals participation in the study
Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of study drug(s) (inactivated, viral vector vaccines, and messenger RNA (mRNA) vaccines are allowed; seasonal vaccines should be up to date prior to planned Cycle 1 Day 1)
Parts C (Dose Escalation) and D (Dose Expansion): Combination Cohorts:
Individuals with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and individuals with a history of bowel obstruction or gastrointestinal perforation within 6 months prior to planned Cycle 1 Day 1
Individuals who previously received topoisomerase 1 inhibitors or antibody-drug conjugates containing a topoisomerase 1 inhibitor
Known severe intolerance or life-threatening hypersensitivity reactions to humanized monoclonal antibodies or intravenous (IV) immunoglobulin preparations; any history of anaphylaxis; history of human anti-human antibody response
What this trial measures
- The Number of Participants with Dose Limiting Toxicities (DLTs) During Dose EscalationFirst dose up to 30 days post last dose (Up to approximately 109 weeks).
DLTs are defined as any of the following treatment-emergent adverse events (AEs) regardless of attribution (graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), unless clearly related to an underlying disease or extraneous causes, with onset within the DLT-evaluation period for the corresponding dose.
- The Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)First dose up to 30 days post last dose (Up to approximately 109 weeks).
- The Incidence of Laboratory AbnormalitiesFirst dose up to 30 days post last dose (Up to approximately 109 weeks).