Study of HLD-0915 in Patients With Metastatic Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HLD-0915 Hard Capsule, HLD-0915 Tablet, HLD-0915 Soft Capsule.
- Who it may be relevant to
- Registry conditions: Metastatic Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase 1/2 Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Overview
Assessment of the safety and efficacy of HLD-0915 in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.
Detailed description
This is a Phase 1/2 study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of oral single-agent HLD-0915.
The study includes an initial Phase 1 open-label portion to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) of HLD-0915 as monotherapy, followed by Phase 2 expansion cohorts to further evaluate the safety and efficacy of HLD-0915.
Phase 1 is conducted in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior systemic therapies. Phase 1 includes Part 1, an open-label monotherapy dose-escalation using a Bayesian optimal interval with backfill (BF-BOIN) design. Phase 1 also includes Part 2 (open-label), which evaluates the relative bioavailability of HLD-0915 formulations.
Phase 2 will evaluate the safety, PK, and anti-tumor activity of HLD-0915 administered at the RDEs. Phase 2, Part 1 will randomize patients and assess dose strengths in patients with mCRPC to support registrational dose selection. Additional Phase 2 open-label expansion cohorts will further evaluate preliminary safety and efficacy in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Interventions
- Drug HLD-0915 Hard Capsule
Experimental: Oral HLD-0915 - Drug HLD-0915 Tablet
Experimental: Oral HLD-0915 - Drug HLD-0915 Soft Capsule
Experimental: Oral HLD-0915
Primary outcome measures
- Frequency of dose-limiting toxicities (DLTs) [Time frame: 21 days]
- Frequency and severity of AEs and abnormal ECG, laboratory and clinical changes since baseline [Time frame: 21 days]
- Phase 1 Part 2 (formulation exploration) relative bioavailability [Time frame: 22 days]
Secondary outcome measures (6)
- PK Parameters [Time frame: 21 days]
- Change in PSA over time [Time frame: 21 days]
- Objective Response Rate (ORR) [Time frame: 63 days]
- Duration of Response (DOR) [Time frame: 21 days]
- Radiographic Progression-Free Survival (rPFS) [Time frame: 63 days]
- Time to Response (TTR) [Time frame: 63 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 11 centers
- Sarah Cannon Research Institute at HealthONE — Denver
- Yale - New Haven Hospital - Yale Cancer Center — New Haven
- Florida Cancer Specialists — Sarasota
- Massachusetts General Hospital — Boston
- START Midwest, LLC — Grand Rapids
- Memorial Sloan Kettering Cancer Center — New York
- Duke University Medical Center — Durham
- Carolina Urologic Research Center, LLC — Myrtle Beach
- … and 3 more centers
United Kingdom · 1 center
- Royal Marsden Hospital — Sutton
Identifiers
NCT: NCT06800313 · HLD-0915-ONC-101