RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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

Quick Facts

Study Start:2024-07-26

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06532565

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 1. Parts A-D: Pretreatment tumor tissue is required. 2. Parts A and C backfill cohorts: Participants must agree to fresh pre- and on-treatment biopsies. * Adequate organ function.	* 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 longer), 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).

Inclusion Criteria

Exclusion 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:
1. Parts A-D: Pretreatment tumor tissue is required.
2. Parts A and C backfill cohorts: Participants must agree to fresh pre- and on-treatment biopsies.
* Adequate organ function.

* 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 longer), 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).

Contacts and Locations

Study Contact

Gilead Clinical Study Information Center

CONTACT

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

GileadClinicalTrials@gilead.com

Principal Investigator

Gilead Study Director

STUDY_DIRECTOR

Gilead Sciences

Study Locations (Sites)

Stanford Cancer Center

Palo Alto, California, 94305

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

NEXT Oncology

San Antonio, Texas, 78229

United States

NEXT Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Gilead Sciences

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-26

Study Completion Date2028-06

Study Record Updates

Study Start Date2024-07-26

Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumors