Actively Recruiting
Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors
Led by Gilead Sciences · Updated on 2026-04-21
154
Participants Needed
6
Research Sites
200 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-2121 when given alone or in combination with zimberelimab (ZIM) in participants with advanced solid tumors. The primary objectives of this study are: * To assess the safety and tolerability of GS-2121 as monotherapy and GS-2121 in combination with zimberelimab in participants with advanced solid tumors. * To identify the maximum tolerated dose (MTD) / maximum administered dose (MAD) and/or the recommended phase 2 dose (RP2D) of GS-2121 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.
CONDITIONS
Official Title
Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with advanced solid tumors confirmed by tissue analysis
- Tumors have progressed despite standard therapy, or standard therapy is not suitable or tolerated
- Measurable disease according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Availability of pre-treatment tumor tissue
- Agreement to provide fresh pre- and on-treatment biopsies for certain study parts
- Adequate organ function
You will not qualify if you...
- Positive pregnancy test or currently breastfeeding
- Need for ongoing prohibited medications
- Received major surgery within 4 weeks prior to study start
- Received experimental therapy within 21 days or 5 half-lives prior to study start
- Received approved immunotherapy or biologic therapy within 28 days prior to study start
- Received chemotherapy within 21 days (or 42 days for specific drugs) prior to study start
- Received targeted small molecule therapy within 14 days or 5 half-lives prior to study start
- Received hormonal or adjunctive cancer therapy within 14 days prior to study start
- Received radiation therapy within 21 days prior to study start
- Prior allogeneic tissue or solid organ transplantation
- Not recovered from previous treatment side effects
- Active central nervous system metastases or leptomeningeal disease
- Immunodeficiency diagnosis
- History of or active autoimmune disease requiring systemic treatment within 2 years
- Active second cancer
- Uncontrolled or symptomatic infections requiring systemic treatment
- History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis
- Symptomatic ascites or pleural effusion needing medical intervention
- Active hepatitis B, hepatitis C, or HIV infection
- Recent serious heart conditions or abnormal heart function
- Received live vaccines within 28 days before starting study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Stanford Cancer Center
Palo Alto, California, United States, 94305
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
4
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
5
The Ottawa Hospital Cancer Centre
Ottawa, Canada, K1H 8L6
Actively Recruiting
6
Princess Margaret Cancer Centre
Toronto, Canada, M5G1Z5
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
4
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