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RECRUITING Phase 1 ClinicalTrials.gov

Study of GS-2426 in Participants With Advanced Solid Tumors

Sponsor: Gilead Sciences • ClinicalTrials.gov ID: NCT07601243

Registry updated: 2026-10-14
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Description

The goal of this clinical study is to learn more about the study drug GS-2426, and how safe and tolerable it is in participants with advanced methylthioadenosine phosphorylase (MTAP)-deleted solid tumors. The primary objective of this study is to evaluate the safety and tolerability of GS-2426 in participants with MTAP-deleted advanced solid tumors and to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended phase II dose (RP2D).

Interventions

  • GS-2426 (Drug)
    Administered Orally

Eligibility criteria

Key Inclusion Criteria: * Participants 18 years of age or older (≥ 19 years old for participants in South Korea). * Histologically or cytologically confirmed advanced malignant solid tumors, who have progressed on, are intolerant to or are ineligible for standard therapy, or have no standard treatment options. * Participant tumors are methylthioadenosine phosphorylase (MTAP)-deficient. * Adequate organ function * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * All participants must provide a pretreatment tumor tissue sample. Key Exclusion Criteria: * Participants with plans to breastfeed during the study period or within 7 days following the last dose of study intervention. * Have not recovered (ie, returned to Grade 1 or baseline) from clinically significant adverse events (AEs) due to a previously administered agent or a previous intervention as assessed by the investigator. * Active second malignancy. Individuals with a history of malignancy who have been completely treated with no evidence of active cancer for 5 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence may be enrolled. * Requirement for ongoing therapy with any prohibited medications . * Prior therapy with a protein arginine methyltransferase 5 (PRMT5) inhibitor or methionine adenosine transferase 2a (MAT2A) inhibitor. * Have serious infection requiring antibiotics within 14 days prior to the first dose. * Uncontrolled concurrent diseases Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Conditions

Advanced Solid Tumors

Locations

  • Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
  • START Midwest — Grand Rapids, Michigan, United States
  • START Astera, LLC — East Brunswick, New Jersey, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • START San Antonio, LLC — San Antonio, Texas, United States
  • START Madrid- CIOCC - Hospital HM Sanchinarro — Madrid, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record