GS-2426 in MTAP-deleted advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial evaluates the safety and tolerability of GS-2426 in adults whose MTAP-deficient solid tumors have progressed after standard therapies or lack effective options. The study aims to determine the maximum tolerated dose, the maximum administered dose, and a recommended dose for phase II testing. Eligible participants have good organ function, an ECOG score of 0-1, and must provide a pretreatment tumor sample. Key exclusions include planned breastfeeding, unresolved significant adverse events, and active second malignancies. The trial is led by Gilead Sciences with sites in Boston, Grand Rapids, and East Brunswick.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Gilead Clinical Study Information Center
• Email: GileadClinicalTrials@gilead.com
• Phone: 1-833-445-3230 (GILEAD-0)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.