RecruitingPhase 1Phase 2NCT06800313

A Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Phase 1/2 Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)


Sponsor

Halda Therapeutics OpCo, Inc.

Enrollment

33 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Assessment of the safety and efficacy of HLD-0915 as monotherapy in patients with metastatic castration resistant prostate cancer (mCRPC) that have progressed on prior systemic therapies, once a recommended dose for expansion (RDE) has been determined in Phase 1 of the trial.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new drug called HLD-0915 in men with metastatic castration-resistant prostate cancer — meaning prostate cancer that has spread and is no longer responding to hormone-blocking treatments. **You may be eligible if...** - You are a man aged 18 or older - You have prostate cancer confirmed by biopsy - You have had surgical or medical hormone suppression (testosterone reduced to castrate levels) - Your cancer has continued to progress despite previous treatments - You are in reasonably good general health (able to carry out light activities) - Your life expectancy is at least 3 months - You have adequate kidney, liver, and blood count function **You may NOT be eligible if...** - You have significant heart, liver, or other major organ problems - You are receiving other active cancer treatments - You have untreated brain metastases 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

DRUGHLD-0915

A treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)


Locations(11)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Yale - New Haven Hospital - Yale Cancer Center

New Haven, Connecticut, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

START Midwest, LLC

Grand Rapids, Michigan, United States

Evelyn H. Lauder Breast and Imaging Center (BAIC)

New York, New York, United States

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

NEXT Austin

Austin, Texas, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Royal Marsden Hospital

Sutton, Surrey, United Kingdom

View Full Details on ClinicalTrials.gov

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

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NCT06800313


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