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

Study Identifier:
GH31C101A
CT.gov Identifier:
NCT07601243
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study 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).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
N/A
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Phase 1a: Monotherapy Dose Escalation
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Drug: 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: Drug: GS-2426
Drug: Administered Orally
Drug: EXPERIMENTAL: Phase 1b: Monotherapy Dose Expansion
Drug: 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.
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements 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 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 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
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START New Jersey
East Brunswick, NJ, United States, 08816
Investigator
Bruno Fang
Status
Will Be Recruiting
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Amita Patnaik
Status
Will Be Recruiting
Condition(s) Treated at Site