RecruitingPhase 1NCT07137871

Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy

Phase 1 Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy (CTMS# 24-0096)


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

35 participants

Start Date

Oct 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the safety of avasopasem in combination with CDK 4/6 inhibitor and hormonal therapy in women with metastatic hormone receptor positive breast cancer, and to see if the addition of avasopasem improves the effectiveness of a CDK 4/6 inhibitor and hormonal therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called avasopasem in people with hormone receptor-positive (HR+), HER2-negative metastatic breast cancer — a type of breast cancer that is fueled by estrogen or progesterone and has spread to other parts of the body — whose cancer progressed while on CDK 4/6 inhibitor therapy combined with hormonal therapy. **You may be eligible if...** - You have HR+, HER2-negative breast cancer that has spread to other parts of your body (metastatic) - Your cancer progressed on ribociclib or abemaciclib (specific CDK 4/6 inhibitors) combined with hormonal therapy - You are in adequate overall health and your organ function meets study requirements **You may NOT be eligible if...** - Your cancer progressed on palbociclib only (you must have been on ribociclib or abemaciclib) - You have uncontrolled brain metastases - You have received more than 2 prior chemotherapy regimens for metastatic disease - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding 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

DRUGAvasopasem

Avasopasem has also been shown to exhibit both antitumor effects as well as minimal toxicity. Participants are currently taking a CDK 4/6 inhibitor and hormonal therapy


Locations(1)

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, United States

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NCT07137871


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