Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Phase 1/2 Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
About This Trial
- This clinical trial is testing an experimental pill to see how safe it is and how well it works against advanced prostate cancer.
- It is designed for adult men whose cancer has spread to other areas of the body, including those whose disease has continued to grow despite prior hormone treatments.
- To take part, you must be able to swallow pills and have adequate liver, kidney, and blood health, with no history of serious bleeding disorders.
- Because this is an early-stage study, doctors will closely monitor participants to watch for side effects and determine the most effective dose.
More Information
- Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This clinical trial is testing an experimental pill to see how safe it is and how well it works against advanced prostate cancer.
Study Details
- Start Date: February 6, 2025
- Lead Sponsor: Janssen Research & Development, LLC
Full Eligibility Criteria
Patients must meet the following criteria to be eligible study participation:
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
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
Treatments
- Drug: JNJ-101556143 Formulation 1
- Drug: JNJ-101556143 Formulation 2
- Drug: JNJ-101556143 Formulation 3