HLD-0915-ONC-101
Prostate cancer
A Phase 1/2, open-label study of JNJ-101556143* in participants with mCRPC
Phase
Compound
JNJ-101556143*
NCT identifier
NCT06800313
Enrollment
N=~33
For more information, including
contact details, please visit
ClinicalTrials.gov
contact details, please visit
ClinicalTrials.gov
Study overview & design
Key eligibility criteria†:
Key eligibility criteria for Phase 1 and Phase 2:
- Progressive mCRPC defined as having demonstrated PSA progression on the prior regimen
- Prior orchiectomy or ongoing ADT and a castrate level of serum testosterone
Key eligibility criteria for Part 2A, 2B, 2C, and 2D:
- SOAR arm (Phase 2 Part 2A): mHSPC with distant metastatic disease based on conventional imaging; PSA ≥0.2 ng/mL, after next generation ARPI for ≥180 to 365 days; no evidence of radiographic or PSA progression while receiving ARPI
- mHSPC arms (Phase 2 Part 2B, 2C, and 2D): serum testosterone >150ng/ml mHSPC with distant metastatic disease based on conventional imaging and PSA >2.0 ng/mL
Study
design
Primary outcomes:
- DLTs
- Frequency and severity of AEs and abnormal ECG
- Relative bioavailability
Secondary outcomes:
- PK
- Change in PSA over time
- ORR per RECIST
- DOR
- rPFS
- TTR
*Other name: HLD-0915. †Not a complete list of inclusion and exclusion criteria.
ADT, androgen
deprivation therapy; AE, adverse event; ARPI, androgen receptor pathway inhibitor; DLT, dose-limiting toxicity; DOR,
duration of response; mCRPC, metastatic castration-resistant prostate cancer; mHSPC, metastatic
hormone-sensitive prostate cancer; ORR, objective response rate; PK, pharmacokinetics; PSA, prostate-specific
antigen; RECIST, Response Evaluation Criteria in Solid Tumors; rPFS, radiographic progression-free survival; TTR,
time to response.