Testing HLD-0915 for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Patients must meet the following criteria to be eligible study participation:

Key Inclusion Criteria:

All Study Arms (Phase 1 Part 1 \& 2, Phase 2 Part 1, Part 2A, 2B, 2C \& 2D):

Males ≥ 18 years old Histological, pathological, and/or cytological confirmation of prostate adenocarcinoma Adequate hematological, renal, and hepatic function. Able to swallow oral medication

mCRPC Arms: (Phase 1 Part 1 \& 2, Phase 2 Part 1): Prior orchiectomy or ongoing androgen-deprivation therapy and a castrate level of serum testosterone Progressive mCRPC defined as having demonstrated PSA progression on the prior regimen

SOAR Arm (Phase 2 Part 2A) mHSPC with distant metastatic disease based on conventional imaging PSA ≥0.2 ng/mL, following treatment with next generation ARPI for at least 180 days and up to 365 days No evidence of radiographic or PSA progression while receiving ARPI

mHSPC arms (Phase 2 Part 2B, 2C \& 2D) serum testosterone \>150ng/ml mHSPC with distant metastatic disease based on conventional imaging and PSA \>2.0 ng/mL

Key Exclusion Criteria:

All arms (Phase 1 Part 1 \& 2, Phase 2 Part 1, Part 2A, 2B, 2C \& 2D):

Has experienced a recent major bleed or has a known bleeding disorder Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology Receiving continuous corticosteroids at prednisone-equivalent dose of \>10 mg/day Prior or ongoing significant medical condition

mCRPC arms: (Phase 1 Part 1 \& 2, Phase 2 Part 1): Has received systemic anti-cancer therapy or investigational drugs within 2 weeks prior to first dose of study drug with certain exceptions requiring longer washout periods

SOAR arm (Phase 2 Part 2A) Has received any prior cytotoxic chemotherapy for prostate cancer

mHSPC arms (Phase 2 Part 2B, 2C \& 2D) regional pelvic lymph node disease only

Where it's running

• Rocky Mountain Cancer Center
  Colorado Springs, Colorado, United States Recruiting
• Sarah Cannon Research Institute 1
  Denver, Colorado, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• Florida Cancer Specialists
  Sarasota, Florida, United States Recruiting
• XCancer Research Network LCMC Health EJGH
  Metairie, Louisiana, United States Recruiting
• Dana Farber Mass General Brigham Cancer Care Inc
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.