Phase 1/2 Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
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Study Summary
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. To characterize the PK profile and assess clinical activity by PSA decline and objective response rate per RECIST and will explore ctDNA, tumor cell genetics, and PD biomarkers. To evaluate the first-in-class RIPTAC therapeutic, HLD-0915 in patients with metastatic castration-resistant prostate cancer. To evaluate monotherapy safety, tolerability, and clinical activity of orally administered HLD-0915 AR-BRD4 RIPTAC™ therapeutic in patients with mCRPC.
This multi-phase, multi-part study evaluates safety, PK, and preliminary efficacy of HLD-0915 across mPC disease states, while supporting dose selection and formulation development. Phase 1: Part 1 (Dose Escalation) uses a BF-BOIN design to identify the MTD and RDE. This adaptive approach allows enrollment at doses already shown to be safe, generating additional safety, tolerability, and early activity data to inform dose selection. Part 2 (Formulation Exploration) evaluates the relative bioavailability of new HLD-0915 formulations at doses demonstrated to be safe. Phase 2: Part 1 (Dose Optimization) evaluates anti-tumor activity at different randomized RDE(s) while continuing to assess safety and PK. Part 2 (Parts 2A,2B,2C,2D) Expansion Cohorts assesses safety and early efficacy at the RDE (or highest dose deemed safe) in defined metastatic HSPC populations. The design aims to establish dose and formulation and to characterize therapeutic potential across mPC populations.
- 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
Clinical Study Information for Healthcare Providers
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