Actively Recruiting
Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors
Led by Gilead Sciences · Updated on 2025-03-12
254
Participants Needed
7
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and give written informed consent
- Assigned female or male at birth, 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Measurable disease by RECIST v1.1 criteria by investigator assessment
- Adequate hematologic function
- Adequate hepatic function
- Adequate creatinine clearance
- Adequate coagulation
- Pre-treatment tumor tissue required for Parts A, B, C, and D
- Agree to fresh pre- and on-treatment biopsies for Parts A and C backfill biopsy cohorts
- Participants assigned male at birth and female participants of childbearing potential engaging in heterosexual intercourse must agree to use protocol-specified contraception
- Willing and able to comply with study requirements and restrictions
- Histologically/cytologically confirmed progressive/advanced solid tumors with selected molecular lesions (Part A)
- Have received, been intolerant to, or ineligible for all known beneficial treatments or have contraindications (Part A)
- Histologically/cytologically confirmed progressive/advanced selected solid tumor diagnoses with defined molecular lesions (Cohort B1)
- May need to forgo approved agents to participate (Cohort B1)
- Histologically/cytologically confirmed progressive/advanced solid tumor diagnoses with defined molecular lesions not in Cohort B1 (Cohort B2)
- Have received, been intolerant to, or ineligible for all known beneficial treatments or have contraindications (Cohort B2)
- Histologically/cytologically confirmed unresectable locally advanced/metastatic selected solid tumors (Part C)
- Histologically/cytologically confirmed unresectable locally advanced or metastatic triple-negative breast cancer (Cohort D1)
- Histologically/cytologically confirmed unresectable locally advanced or metastatic HR+/HER2- breast cancer (Cohort D2)
You will not qualify if you...
- Pregnant or lactating females
- Known hypersensitivity to study drugs, metabolites, or excipients
- Need for ongoing therapy with prohibited medications
- Diagnosis or suspicion of myelodysplastic syndrome or acute myeloid leukemia
- Refractory nausea/vomiting, chronic gastrointestinal disease, inability to swallow study drug, or significant bowel resection precluding absorption
- Major surgery within 4 weeks before Cycle 1 Day 1
- Immunotherapy or biologic therapy within 21 days before Cycle 1 Day 1
- Chemotherapy within 14 days before Cycle 1 Day 1 (42 days for mitomycin or nitrosoureas)
- Targeted small molecule therapy within 14 days before Cycle 1 Day 1
- Experimental therapy within 21 days or 5 half-lives before Cycle 1 Day 1
- Hormonal or adjunctive cancer therapy started less than 14 days before Cycle 1 Day 1 (exceptions apply)
- Radiotherapy within 2 weeks before Cycle 1 Day 1 if not to target lesion
- Prior allogeneic tissue/solid organ transplantation
- Incomplete recovery from prior adverse events
- Prior treatment with prohibited agents
- Immunodeficiency or need for systemic corticosteroids over 10 mg prednisone daily
- Active second malignancy
- Known active CNS metastases or carcinomatous meningitis
- Recent serious cardiac events or arrhythmias
- QT interval over 470 msec
- Advanced heart failure or low left ventricular ejection fraction
- Active serious infection requiring antimicrobials
- Active hepatitis B, hepatitis C, or HIV infection
- History of pneumonitis requiring corticosteroids or radiation pneumonitis requiring steroids
- Symptomatic ascites or pleural effusion
- Other medical or psychiatric conditions interfering with study
- Use of live vaccines within 4 weeks of study drug initiation
- Active chronic inflammatory bowel disease or recent bowel obstruction/perforation for combination cohorts
- Prior exposure to topoisomerase 1 inhibitors or related antibody-drug conjugates
- Severe intolerance or life-threatening allergic reactions to monoclonal antibodies or IV immunoglobulin
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02459
Actively Recruiting
2
NEXT Austin
Austin, Texas, United States, 78758
Actively Recruiting
3
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
4
NEXT Dallas
Irving, Texas, United States, 75039
Actively Recruiting
5
Rambam Health Care Campus
Haifa, Israel, 31096
Actively Recruiting
6
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
7
Chaim Sheba Medical Center
Tel Litwinsky, Israel, 52621
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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