Study of GS-2426 in Participants With Advanced Solid Tumors

Part of paid clinical trials in East Brunswick, New Jersey.

Sponsor
Gilead Sciences
Study ID
NCT07601243
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GS-2426 — DRUG
    Administered Orally

Study Details

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).

Key Dates

Start date
Jun 2, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
174 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a: Monotherapy Dose Escalation
    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.
  • Experimental: Phase 1b: Monotherapy Dose Expansion
    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.

Primary Outcome Measure

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) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
START Astera, LLCEast BrunswickNew Jersey08816-
START San Antonio, LLCSan AntonioTexas78229-

Find similar trials in East Brunswick, NJ

By research site
START Astera, LLC· East Brunswick, NJSTART San Antonio, LLC· San Antonio, TX

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