Metastatic Prostate Cancer
Conditions
Keywords
Prostate Cancer, RIPTAC, HLD-0915, Genital Neoplasms, Male, Urogenital Neoplasms, Male, Genital Diseases, Male, Urogenital Diseases, Male, Neoplasms, Glandular and Epithelial, Prostatic Neoplasms, Prostate Adenocarcinoma, Hormone Sensitive, Castrate Resistant, Metastatic Castrate Resistant Prostate Cancer
Brief summary
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.
Interventions
DRUGJNJ-101556143 Formulation 1
Experimental: Oral JNJ-101556143
DRUGJNJ-101556143 Formulation 2
Experimental: Oral JNJ-101556143
DRUGJNJ-101556143 Formulation 3
Experimental: Oral JNJ-101556143
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of dose-limiting toxicities (DLTs) | 21 days |
| Frequency and severity of AEs and abnormal ECG, laboratory and clinical changes since baseline | 21 days |
| Phase 1 Part 2 (formulation exploration) relative bioavailability | 22 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Parameters | 21 days | — |
| Change in PSA over time | 21 days | Including PSA50 and PSA90 response |
| Objective Response Rate (ORR) | 63 days | Per RECIST in evaluable patients |
| Duration of Response (DOR) | 21 days | — |
| Radiographic Progression-Free Survival (rPFS) | 63 days | — |
| Time to Response (TTR) | 63 days | — |
Countries
United Kingdom, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed