RecruitingPhase 1NCT06950034

A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)

A Phase 1, Open-Label, Dose Escalation and Expansion Study of STX-0712 in Patients With Advanced Hematologic Malignancies


Sponsor

Solu Therapeutics, Inc

Enrollment

105 participants

Start Date

Mar 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a first-in-human, multicenter, open-label, phase 1 study to evaluate the safety, PK, PD and preliminary efficacy of STX-0712 in patients with advanced CMML and AML for whom there are no further treatment options known to confer clinical benefit.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study is testing a new drug called STX-0712 for people with two specific types of blood cancers: chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) — specifically the type that involves a large proportion of monocytic (immune-related) cancer cells. The study is evaluating the safety and appropriate dose of this experimental therapy. **You may be eligible if...** - You have been diagnosed with CMML that has not responded to or has relapsed after at least 4 cycles of standard treatment - You have relapsed or refractory monocytic or monocytic-predominant AML with a low white blood cell count - You are in reasonable health (ECOG performance status 2 or below) with a life expectancy of at least 2 months - You have adequate organ function **You may NOT be eligible if...** - You have active uncontrolled infection or other serious medical conditions - You are unwilling to use contraception if you are of childbearing potential - You do not have the specific CMML or monocytic AML diagnosis required for this trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSTX-0712

STX-0712 is IV administered every 21 days until the patient discontinues treatment.


Locations(7)

Stanford University

Stanford, California, United States

Moffitt

Tampa, Florida, United States

DFCI

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

OHSU

Portland, Oregon, United States

Vanderbilt University

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06950034


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