HLD-0915-ONC-101
Prostate cancer
A Phase 1/2 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†:
- Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate
- Prior orchiectomy and/or ongoing ADT and a castrate level of serum testosterone
- Progressed on prior LOT
- Received ≥1 prior ARPI
- Progressive mCRPC defined as having demonstrated PSA progression on the prior regimen
- ECOG PS 0 or 1
- Adequate hematological, renal, and hepatic function
Study
design
Primary outcomes:
Phase 1
- DLTs
- Frequency and severity of AEs and SAEs
Secondary outcomes:
Phase 1
- PK
- PSA decline ≥30%, ≥50%, and ≥90%
- Objective response rate per RECIST
- DOR
- rPFS
- TTR
- Change in PSA over time
- ctDNA
*Other name: HLD-0915. †Not a complete list of inclusion and exclusion criteria. ‡BF-BOIN design.
ADT, androgen deprivation therapy; AE, adverse event; ARPI, androgen receptor pathway inhibitor; BF-BOIN, Bayesian optimal interval with backfill; ctDNA, circulating tumor DNA; DLT, dose-limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; LOT, line of therapy; mCRPC, metastatic castration-resistant prostate cancer; PK, pharmacokinetics; PSA, prostate-specific antigen; RECIST, Response Evaluation Criteria in Solid Tumors; rPFS, radiographic progression-free survival; SAE, serious adverse event; TTR, time to response.