Study of GS-2426 in Participants With Advanced Solid Tumors

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).

Eligibility

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.

Conditions2

Interventions1

Locations2 sites

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