Recruiting
Phase 1

GS-2426

Sponsor:

Gilead Sciences

Code:

NCT07601243

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GS-2426

Study Details

Brief summary:

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).

Conditions

Advanced Solid Tumors

Study ID

NCT07601243

Start date

Jun 2, 2026

Status verified date

Jul, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

174 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a: Monotherapy Dose Escalation

Participants will receive escalating doses of GS-2426 monotherapy, until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol, or up to a maximum of 105 week, whichever occurs first.

experimental: Phase 1b: Monotherapy Dose Expansion

Participants will be enrolled in different indication-specific cohorts. Participants will receive GS-2426 monotherapy at the recommended dose until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol, or up to a maximum of 105 weeks, whichever occurs first.

Interventions

GS-2426

Administered Orally

Primary outcome measure

  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) [ Time Frame: First dose up to 30 days post last dose (up to 105 weeks) ]
  • Percentage of Participants Experiencing Clinical Laboratory Abnormalities [ Time Frame: First dose up to 30 days post last dose (up to 105 weeks) ]
  • Percentage of Participants Experiencing Any Dose-limiting Toxicities (DLTs) [ Time Frame: First dose up to 21 days post first dose ]
  • Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD) [ Time Frame: First dose up to 21 days post first dose ]
  • Recommended Phase 2 Dose (RP2D) [ Time Frame: Predose to end of study (up to 105 weeks) ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Locations

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

START Astera, LLC

Recruiting

East Brunswick, New Jersey, United States, 08816

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

START San Antonio, LLC

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Gilead Sciences

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-08-03.