Study on HLD-0915 for Patients with Advanced Prostate Cancer Resistant to Standard Treatments
Sponsor: Halda Therapeutics OpCo, Inc.
ClinicalTrials ID:NCT06800313
This clinical trial is testing a new drug, HLD-0915, to see if it is safe and effective for men with advanced prostate cancer that has not responded to other treatments. The study will first determine the best dose and then evaluate how well the drug works.
Patient Parameters
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Program Overview
The study aims to test the safety and effectiveness of a new drug called HLD-0915 for men with advanced prostate cancer that continues to grow despite other treatments. The trial will start by finding the best dose of the drug and then move on to see how well it works in reducing cancer growth.
Description
This clinical trial is divided into two parts: Phase 1 and Phase 2.
In Phase 1, researchers will determine the safest and most effective dose of HLD-0915 for men with advanced prostate cancer that has not responded to previous treatments. This phase will involve gradually increasing the dose in small groups of patients to find the best dose that can be used in the next phase.
In Phase 2, the study will focus on how well HLD-0915 works in controlling cancer growth at the dose determined in Phase 1. Participants will continue their current hormone therapy unless they have had surgery to remove the testicles.
Throughout the study, participants will take HLD-0915 as a pill and will be monitored for any side effects and changes in their cancer. The study aims to provide new insights into the potential benefits of HLD-0915 for treating advanced prostate cancer.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 or older.
- Able to understand and sign a consent form.
- Confirmed diagnosis of prostate cancer.
- Have had surgery to remove the testicles or are on hormone therapy to lower testosterone levels.
- Cancer has continued to grow despite previous treatments.
- Show signs of cancer progression, such as rising PSA levels.
- Good overall health with a performance status of 0 or 1.
- Expected to live at least 3 more months.
- Have good blood, kidney, and liver function.
- Able to swallow pills.
- Willing to follow the study schedule and requirements.
- If taking bone-strengthening medications, must have been on a stable dose for at least 30 days before joining the study.
Exclusion Criteria
- Recent major bleeding or a known bleeding disorder.
- Tumors with neuroendocrine or small cell features.
- Taking more than 10 mg/day of prednisone or similar steroids.
- Received cancer treatments or experimental drugs within 2 weeks before starting the study, with some exceptions.
- Recent heart attack or severe heart disease within the last 6 months.
- Active or chronic infections.
- Uncontrolled kidney, pancreas, or liver disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| START Midwest, LLC | 49546 | Grand Rapids | Michigan |
| NEXT Austin | 78758 | Austin | Texas |
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