MTX-531-001 Phase 1 Study in Advanced Solid Tumors

Part of paid clinical trials in Newport Beach, California.

Sponsor
MEKanistic Therapeutics, Inc.
Study ID
NCT07874880
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • MTX-531 — DRUG
    MTX-531 is an investigational small-molecule dual EGFR/PI3K inhibitor administered as monotherapy in adults with advanced solid tumors. Dose levels will be evaluated during dose escalation to assess safety, tolerability, pharmacokinetics, and preliminary clinical activity.

Study Details

This is a first-in-human, Phase 1, open-label study evaluating MTX-531, an investigational dual EGFR/PI3K inhibitor, in adults with advanced solid tumors. The study will evaluate the safety and tolerability of MTX-531, determine the maximum tolerated dose and recommended Phase 2 dose, and assess how the drug is processed by the body and its preliminary anti-tumor activity.

Key Dates

First listed
Oct 15, 2026
Start date
Oct 20, 2026
Status verified
Oct 2026
Primary completion
Dec 31, 2028
Completion
Sep 29, 2029

Study Design

Enrollment
71 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MTX-531 Monotherapy
    Participants receive MTX-531 as monotherapy in sequential dose levels to evaluate the safety and tolerability of MTX-531, determine the maximum tolerated dose and recommended Phase 2 dose, and assess pharmacokinetics and preliminary clinical activity.

Primary Outcome Measure

Safety and Tolerability profile of MTX-531 [ Time Frame: From the time of first dose of study drug administration up to 21 days. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663
Holland Orndorff Clinical Research Coordinator
[email protected]
949-764-7110
Patrice Jones Clinical Research Manager
[email protected]
(949) 764-5501

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