Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Key facts
- Where
- Sutton, United KingdomSee the site
- Phase
- Phase 1/2
Where in United Kingdom
- The Royal Marsden NHS TrustSutton, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT06800313
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
Phase 1/2 Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
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.
Inclusion: 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: 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; All arms (Phase 1 Part 1 \& 2, Phase 2 Part 1, Part 2A, 2B, 2C \& 2D):.
Patients must meet the following criteria to be eligible study participation:.