A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer
Janssen Research & Development, LLC
Summary
The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose expansion).
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Part 1 A-G, 1I, 1J, and 1K (all combination treatments) and Parts 2B-C (cabazitaxel, docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by prostate cancer working group 3 (PCWG3); Parts 2D-G, 2I, 2J, and 2K (apalutamide, enzalutamide, darolutamide, abiraterone acetate + prednisone \[AAP\], lutetium Lu-177 vipivotide tetraxetan, JNJ-101556143): mCRPC: Histologically confirmed adenocarcinoma of the prostate as defined by PCWG3, with a minimum PSA of 2 nanogram \[ng\]/milliliter (mL); Part 2H (apaluta…
Interventions
- DrugPasritamig
Pasritamig will be administered.
- DrugCetrelimab
Cetrelimab will be administered by intravenous infusion.
- DrugCabazitaxel
Cabazitaxel will be administered by intravenous infusion.
- DrugDocetaxel
Docetaxel will be administered by intravenous infusion.
- DrugApalutamide
Apalutamide will be administered orally.
- DrugEnzalutamide
Enzalutamide will be administered orally.
- DrugDarolutamide
Darolutamide will be administered orally.
Locations (15)
- Florida Cancer SpecialistsSarasota, Florida
- Start MidwestGrand Rapids, Michigan
- Washington University School Of MedicineSt Louis, Missouri
- Perlmutter Cancer Center at NYU Langone BrooklynBrooklyn, New York
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long IslandMineola, New York
- NYU Langone HealthNew York, New York