NCT06800313 · Halda Therapeutics OpCo, Inc.
A Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
What this study is about
Assessment of the safety and effectiveness of HLD-0915 as treatment given alone 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.
View original scientific description
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.
Interventions
DRUG
HLD-0915 Hard Capsule
Experimental: Oral HLD-0915
DRUG
HLD-0915 Tablet
Experimental: Oral HLD-0915
DRUG
HLD-0915 Soft Capsule
Experimental: Oral HLD-0915
Primary outcome measures
Frequency of dose-limiting toxicities (DLTs)
Time frame: 21 days
Frequency and severity of AEs and abnormal ECG, laboratory and clinical changes since baseline
Time frame: 21 days
Phase 1 Part 2 (formulation exploration) relative bioavailability
Time frame: 22 days
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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. A
Where
- Denver, Colorado
- New Haven, Connecticut
- Sarasota, Florida
- Boston, Massachusetts
- Grand Rapids, Michigan
- New York, New York
- Durham, North Carolina
- Myrtle Beach, South Carolina
- Nashville, Tennessee
- Austin, Texas
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations