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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT07137871
Phase
PHASE1
Status
Recruiting
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Conditions

  • Breast Cancer Metastatic

Eligibility Criteria

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

Interventions

  • Avasopasem — DRUG
    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

Study Details

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.

Key Dates

Start date
Oct 2, 2025
Status verified
Oct 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

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

Arms

  • Experimental: Metastatic Hormone Receptor Positive Breast Cancer
    This study is investigating the addition of a novel agent, Avasopasem (or GC4419), in patients with hormonal receptor positive (HR+) metastatic breast cancer with progression while on treatment with a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor and an aromatase inhibitor.

Primary Outcome Measure

Determine Safety and Tolerability of Treatment [ Time Frame: Day 1 through Day 28 (each cycle is 28 days, up to 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mays Cancer Center, UT Health San AntonioSan AntonioTexas78229
Kayla Chamberlin, RN
[email protected]
210-450-1000
Kate Lathrop, MD
[email protected]
210-450-1000

Find similar trials in San Antonio, TX

By research site
Mays Cancer Center, UT Health San Antonio· San Antonio, TX

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