Study Details

PROTOCOL 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).

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Advanced Solid Tumors

Gender

N/A

Date

June 2026 - January 2029

Study Type

INTERVENTIONAL

Study Phase

PHASE1

Product

GS-2426

Eligibility Information

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.

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.

Locations

Locations (2)

START Astera, LLC

East Brunswick, New Jersey, United States, 08816

START San Antonio, LLC

San Antonio, Texas, United States, 78229

Study of GS-2426 in Participants With Advanced Solid Tumors

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