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

Last updated: December 16, 2024
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

GS-2121

Zimberelimab

Clinical Study ID

NCT06532565
GS-US-579-6764
2024-511739-81
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participants diagnosed with histologically or cytologically confirmed advanced solidtumors who have progressed despite standard therapy, are intolerant to standardtherapy, or are ineligible for standard therapy.

  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1criteria.

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

  • Tissue requirements:

  1. Parts A-D: Pretreatment tumor tissue is required.

  2. Parts A and C backfill cohorts: Participants must agree to fresh pre- andon-treatment biopsies.

  • Adequate organ function.

Exclusion

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 protocolspecified time prior to initiation of study including: major surgery (<4 weeks),experimental therapy (<21 days or <5 half-lives whichever is longer), approvedimmunotherapy or biologic therapy (<28 days), approved chemotherapy (<21 days or <42days for mitomycin or nitrosoureas), approved targeted small molecule therapy (<14days or <5 half-lives whichever is longer), hormonal therapy or other adjunctivetherapy for cancers other than cancer under evaluation in this study (<14 days) orradiation therapy (<21 days).

  • Any prior allogeneic tissue/solid organ transplantation, including allogeneic stemcell transplantation.

  • Have not recovered (ie, returned to Grade 1 or baseline) from AEs due to apreviously administered agent.

  • Have known active central nervous system (CNS) metastases and/or leptomeningealdisease (LMD).

  • Diagnosis of immunodeficiency, either primary or acquired.

  • History of autoimmune disease or active autoimmune disease that has requiredsystemic 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 notcontrolled or requires systemic antibiotics, antifungals, or antivirals,respectively.

  • History of pneumonitis requiring treatment with corticosteroids, interstitial lungdisease, or severe radiation pneumonitis (excluding localized radiationpneumonitis).

  • Ascites or pleural effusion that is symptomatic and/or requiring medicalintervention.

  • Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or HIV.

  • Meet any of the following criteria for cardiac disease: Myocardial infarction orunstable angina pectoris within 6 months of enrollment. History of seriousventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation),high-grade atrioventricular block, or other cardiac arrhythmias requiringantiarrhythmic medications (except for atrial fibrillation that is well controlledwith antiarrhythmic medication). Mean QT interval corrected for heart rate using theFridericia's formula (QTcF) ≥ 470 msec. New York Heart Association Class > IIIcongestive 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.

Study Design

Total Participants: 154
Treatment Group(s): 2
Primary Treatment: GS-2121
Phase: 1
Study Start date:
July 26, 2024
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • The Ottawa Hospital Cancer Centre

    Ottawa, K1H 8L6
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, M5G1Z5
    Canada

    Active - Recruiting

  • Stanford Cancer Center

    Palo Alto, California 94305
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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