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NCT06532565 · Gilead Sciences

Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors

What this study 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.

View original scientific description

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion 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

Exclusion criteria

  • 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 is shorter), approved immunotherapy or biologic therapy (\<28 days), approved chemotherapy (\<21 days or \<42 days for mitomycin or nitrosoureas), approved targeted small molecule therapy (\<14 days or \<5 half-lives whichever is longer), hormonal therapy or other adjunctive therapy for cancers other than cancer under evaluation in this study (\<14 days) or radiation therapy (\<21 days).
  • 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 ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication). Mean QT interval corrected for heart rate using the Fridericia's formula (QTcF) ≥ 470 msec. New York Heart Association Class \> III congestive heart failure or known left ventricular ejection fraction \< 40%.
  • Live vaccines within 28 days of initiation of study drug(s). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where

  • Palo Alto, California
  • Boston, Massachusetts
  • San Antonio, Texas
  • Fairfax, Virginia

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations

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1 of 154 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Palo Alto

California

Location available
RECRUITING

Boston

Massachusetts

Location available
RECRUITING

San Antonio

Texas

Location available
RECRUITING

Fairfax

Virginia

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Advanced Solid Tumors Trials by City

Browse all advanced solid tumors clinical trials in these cities — not just this study.

Looking for Advanced Solid Tumors Treatment in Palo Alto?

Join others in California exploring innovative treatment options through clinical research

Advanced Solid Tumors Treatment Options in Palo Alto, California

If you're searching for Advanced Solid Tumors treatment in Palo Alto, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Palo Alto, Boston, San Antonio and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Advanced Solid Tumors. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 154 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Advanced Solid Tumors?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Advanced Solid Tumors

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Advanced Solid Tumors Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06532565. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.