MTX-531 for Cancer

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: MEKanistic Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, such as colon, endometrial, breast, or head and neck cancers, whose disease has not responded to standard treatments. Participants must be in generally stable health aside from their cancer.

Inclusion Criteria

I have recovered from side effects of past treatments, except for mild or controlled issues.
I have a solid tumor that is not a primary brain tumor.
Coagulation: INR ≤1.5; aPTT ≤1.5 × ULN without anticoagulants or within acceptable parameters on anticoagulants
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Exclusion Criteria

I have not had another cancer in the past 2 years, except low-risk types.
I do not have brain metastases that need steroids or urgent treatment.
I am currently pregnant or breastfeeding.
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What Are the Treatments Tested in This Trial?

Interventions

  • MTX-531

Trial Overview

The study is testing MTX-531, a new drug that blocks EGFR and PI3K pathways involved in cancer growth. It aims to find the safest dose and see how the body handles the drug. All participants receive MTX-531.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: MTX-531 MonotherapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

MEKanistic Therapeutics, Inc.

Lead Sponsor

Translational Drug Development

Collaborator

Trials
19
Recruited
1,000+