A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-95298177, an Antibody Drug Conjugate Targeting Prostate Specific Membrane Antigen, for Prostate Cancer
Janssen Research & Development, LLC
Summary
The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of JNJ-78278343 in combination with JNJ-95298177 in Part 1 (Dose confirmation) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of prostate cancer where the cancer has spread beyond the prostate and is resistant to hormonal therapy) in Part 2 (Dose expansion) of study.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate. Primary small cell carcinoma, carcinoid tumor, neuroendocrine (NE) carcinoma, or large cell NE carcinoma arising in the prostate are not allowed; however, adenocarcinomas with NE features (for example \[e.g.\], immunohistochemistry \[IHC\] with both androgen receptor \[AR\]- and NE-marker positivity) are allowed * Must have metastatic castration-resistant prostate cancer (mCRPC) * PSA must measure at least 2 nanograms per milliliters (ng/mL) at screening * Measurable or evaluable disease * Prior orchiectomy or medi…
Interventions
- DrugJNJ-78278343
JNJ-78278343 will be administered intravenously.
- DrugJNJ-95298177
JNJ-95298177 will be administered intravenously.
Locations (6)
- Florida Cancer SpecialistsSarasota, Florida
- Columbia University Medical CenterNew York, New York
- University Hospitals Cleveland Medical CenterCleveland, Ohio
- Fred Hutchinson Cancer CenterSeattle, Washington
- The Christie Nhs Foundation TrustManchester
- Royal Marsden Hospital (Sutton)Sutton