Testing HLD-0915 for advanced prostate cancer
Phase 1/2 Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
This study is testing a new oral medication called HLD-0915 to see if it can help men with advanced prostate cancer that hasn't responded to other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Halda Therapeutics OpCo, Inc. Industry-sponsored |
| Drugs / interventions | denosumab, chemotherapy, radiation, prednisone |
| Locations | 11 sites (Denver, Colorado and 10 other locations) |
| Trial ID | NCT06800313 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of HLD-0915, an oral medication, in men with metastatic castration-resistant prostate cancer (mCRPC) who have not responded to previous treatments. The study is divided into two phases: the first phase determines the maximum tolerated dose and the second phase assesses the drug's anti-tumor activity at the recommended doses. Participants will continue their androgen deprivation therapy unless they have undergone surgical castration. The trial employs a dose-escalation design to optimize treatment for patients.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with confirmed metastatic castration-resistant prostate cancer who have progressed on prior therapies.
Not a fit: Patients who have not undergone androgen deprivation therapy or those with non-adenocarcinoma prostate cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer who have limited treatment alternatives.
How similar studies have performed: Other studies have shown promise with similar approaches in targeting advanced prostate cancer, but the specific use of HLD-0915 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: All patients must meet the following criteria to be eligible for Phase 1 study participation: 1. Males of age 18 years at the time of signing the informed consent form (ICF). 2. Able to understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures. 3. Patients must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. 4. Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone. 5. Patients must have progressed on prior line(s) of therapy. 6. Patients must have progressive mCRPC defined as having demonstrated PSA progression on the prior regimen. PSA progression may have occurred with or without accompanying radiographic progression. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 8. Life expectancy of at least 3 months. 9. Adequate hematological, renal, and hepatic function. 10. Able to swallow an oral medication. 11. Willing and able to adhere to the study visit schedule and other protocol requirements. 12. Patients on a stable bisphosphonate or denosumab regimen for 30 days prior to enrollment are eligible. Key Exclusion Criteria: Patients with any of the following will be excluded from participation in Phase 1 of the study: 1. Has experienced a recent major bleed or has a known bleeding disorder. 2. Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology. 3. Receiving continuous corticosteroids at prednisone-equivalent dose of \>10 mg/day. 4. Has received systemic anti-cancer therapy (cytotoxic chemotherapy, biologic agent, checkpoint inhibitors, or radiation therapy) or investigational drugs within 2 weeks prior to first dose of study drug with certain exceptions requiring longer washout periods. 5. History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease. 6. Known clinically significant active or chronic infection. 7. Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease.
Where this trial is running
Denver, Colorado and 10 other locations
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States (Recruiting)
- Yale - New Haven Hospital - Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
- Florida Cancer Specialists — Sarasota, Florida, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- START Midwest, LLC — Grand Rapids, Michigan, United States (Recruiting)
- Evelyn H. Lauder Breast and Imaging Center (BAIC) — New York, New York, United States (Recruiting)
- Carolina Urologic Research Center, LLC — Myrtle Beach, South Carolina, United States (Recruiting)
- SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- NEXT Austin — Austin, Texas, United States (Recruiting)
- The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Royal Marsden Hospital — Sutton, Surrey, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Medical Monitor
- Email: ProstateClinicalTrial@haldathera.com
- Phone: 475-273-6214
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.