Study of GS-2426 in Participants With Advanced Solid Tumors

NCT07601243 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: GH31C101A
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE)

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

• Percentage of Participants Experiencing Clinical Laboratory Abnormalities

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

• Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)

  First dose up to 21 days post first dose

• Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD)

  First dose up to 21 days post first dose

• Recommended Phase 2 Dose (RP2D)

  Predose to end of study (up to 105 weeks)

Secondary Outcomes (4)

• Plasma Concentration of GS-2426

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

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

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

• PK Parameters: Cmax of GS-2426

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

• PK Parameters: Tmax of GS-2426

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

Study Arms (2)

Phase 1a: Monotherapy Dose Escalation

EXPERIMENTAL

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.

Drug: GS-2426

Phase 1b: Monotherapy Dose Expansion

EXPERIMENTAL

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.

Drug: GS-2426

Interventions

GS-2426 DRUG

Administered Orally

Phase 1a: Monotherapy Dose Escalation; Phase 1b: Monotherapy Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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 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 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share