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New treatment option for Advanced Solid Tumors
Official title Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06532565
What this study is testing
What is GS-2121?
GS-2121 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants diagnosed with histologically or cytologically confirmed advanced solid tumors who have progressed despite standard therapy, are...
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Tissue requirements:
- Parts A-D: Pre-treatment tumor tissue is required.
You likely can't join if
- Positive serum pregnancy test or participant who is breastfeeding.
- Requirement for ongoing therapy with any prohibited medications.
- Any anti-cancer therapy, whether investigational or approved within protocol specified time prior to initiation of study including: major surgery...
- Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation.
- Have not recovered (ie, returned to Grade 1 or baseline) from AEs due to a previously administered agent.
- Have known active central nervous system (CNS) metastases and/or leptomeningeal disease (LMD).
See the full eligibility criteria
- Participants diagnosed with histologically or cytologically confirmed advanced solid tumors who have progressed despite standard therapy, are intolerant to standard therapy, or are ineligible for standard therapy.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Tissue requirements:
- Parts A-D: Pre-treatment tumor tissue is required.
- Parts A and C backfill cohorts: Participants must agree to fresh pre- and on-treatment biopsies.
- Adequate organ function. Key
- Positive serum pregnancy test or participant who is breastfeeding.
- Requirement for ongoing therapy with any prohibited medications.
- Any anti-cancer therapy, whether investigational or approved within protocol specified time prior to initiation of study including: major surgery (\<4 weeks), experimental therapy (\<21 days or \<5 half-lives whichever...
- Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation.
- Have not recovered (ie, returned to Grade 1 or baseline) from AEs due to a previously administered agent.
- Have known active central nervous system (CNS) metastases and/or leptomeningeal disease (LMD).
- Diagnosis of immunodeficiency, either primary or acquired.
- History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study treatment.
- Have an active second malignancy.
- Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.
- History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis).
- Ascites or pleural effusion that is symptomatic and/or requiring medical intervention.
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or HIV.
- 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...
- Live vaccines within 28 days of initiation of study drug(s). Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Boston, Massachusetts, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Ottawa, Canada
- Toronto, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Boston, Massachusetts, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States; Ottawa, Canada; Toronto, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.