Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06532565

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Ottawa Hospital Cancer Centre, Ottawa, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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.

Treatment and study plan

GS-2121

Drug

Tablet administered orally

Zimberelimab

Drug

Administered intravenously

Other names: GS-0122, AB122

Primary outcomes

  1. Parts A and B: Percentage of Participants with Adverse Events and Serious Adverse Events

    Time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)

  2. Parts A and B: Percentage of Participants with Laboratory Abnormalities

    Time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)

  3. Part A: Percentage of Participants with Dose-Limiting Toxicities (DLTs) During Dose Escalation

    Time frame: Day 1 up to Day 21

    DLTs are defined as any of the protocol-specified treatment-emergent adverse events (AEs) with onset within the DLT-evaluation period for the corresponding dose.

  4. Parts C and D: Percentage of Participants with Adverse Events and Serious Adverse Events

    Time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)

  5. Parts C and D: Percentage of Participants with Laboratory Abnormalities

    Time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)

  6. Part C: Percentage of Participants with DLTs During Dose Escalation

    Time frame: Day 1 up to Day 21

    DLTs are defined as any of the protocol-specified treatment-emergent adverse events (AEs) with onset within the DLT-evaluation period for the corresponding dose.

Secondary outcomes

  1. Parts A and B: Plasma Concentration of GS-2121 and Active Metabolite

    Time frame: Predose and postdose up to end of treatment (up to 105 weeks)

  2. Parts A and B: PK Parameter: AUC0-24 of GS-2121

    Time frame: Predose and postdose up to end of treatment (up to 105 weeks)

    AUC0-24 is defined as the partial area under the concentration of drug over time between time 0 and time 24 hours. PK parameters will be estimated as applicable, based on the availability of data.

  3. Parts A and B: PK Parameter: Cmax of GS-2121

    Time frame: Predose and postdose up to end of treatment (up to 105 weeks)

    Cmax is defined as the maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data.

  4. Parts A and B: PK Parameter: Tmax of GS-2121

    Time frame: Predose and postdose up to end of treatment (up to 105 weeks)

    Tmax is defined as the time to maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data.

  5. Parts C and D: Plasma Concentration of GS-2121 and Active Metabolite

    Time frame: Predose and postdose up to end of treatment (up to 105 weeks)

  6. Parts C and D: PK Parameter: AUC0-24 of GS-2121

    Time frame: Predose and postdose up to end of treatment (up to 105 weeks)

    AUC0-24 is defined as the partial area under the concentration of drug over time between time 0 and time 24 hours. PK parameters will be estimated as applicable, based on the availability of data.

  7. Parts C and D: PK Parameter: Cmax of GS-2121

    Time frame: Predose and postdose up to end of treatment (up to 105 weeks)

    Cmax is defined as the maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data.

  8. Parts C and D: PK Parameter: Tmax of GS-2121

    Time frame: Predose and postdose up to end of treatment (up to 105 weeks)

    Tmax is defined as the time to maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data.

Study contacts

Contact information is provided by the study sponsor or research team.

Gilead Clinical Study Information Center

CONTACT

[email protected]

1-833-445-3230 (GILEAD-0)

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-2121 as Monotherapy and in Combination in Adults With Advanced Solid Tumors

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 1, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.