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NCT Number: NCT07601243

Study of GS-2426 in Participants With Advanced Solid Tumors

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

START Astera, LLC, East Brunswick, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

GS-2426

Drug

Administered Orally

Primary outcomes

  1. 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)

  2. Percentage of Participants Experiencing Clinical Laboratory Abnormalities

    Time frame: First dose up to 30 days post last dose (up to 105 weeks)

  3. Percentage of Participants Experiencing Any Dose-limiting Toxicities (DLTs)

    Time frame: First dose up to 21 days post first dose

  4. Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD)

    Time frame: First dose up to 21 days post first dose

  5. Recommended Phase 2 Dose (RP2D)

    Time frame: Predose to end of study (up to 105 weeks)

Secondary outcomes

  1. Plasma Concentration of GS-2426

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

  2. Pharmacokinetic (PK) Parameter: AUC0-24h of GS-2426

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

    AUC0-24h is defined as the area under concentration versus time from 0 to 24 hours.

  3. PK Parameters: Cmax of GS-2426

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

    Cmax is defined as the maximum observed plasma drug concentration.

  4. PK Parameters: Tmax of GS-2426

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

    Tmax is defined as the time to peak plasma drug concentration of GS-2426.

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, Multicenter, Open-Label Clinical Study to Evaluate the Safety and Tolerability of GS-2426 in Participants With Advanced MTAP-Deleted Solid Tumors

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 22, 2026
Registry last updated
Jun 24, 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.

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