A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Castration-Resistant Prostate Cancer
Conditions
Metastatic Castration-resistant Prostate NeoplasmsDrugs
JNJ-78278343, Cetrelimab, Cabazitaxel, Docetaxel, Apalutamide, Enzalutamide, Darolutamide, Abiraterone acetate plus prednisone (AAP)Summary
The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).
Locations
3 locations Found with status Recruiting
Status
- RECRUITING
Central Contacts
- Study Contact
- 844-434-4210
- [email protected]
Study Director
- Janssen Research & Development, LLC Clinical Trial
Status
- RECRUITING
Central Contacts
- Study Contact
- 844-434-4210
- [email protected]
Study Director
- Janssen Research & Development, LLC Clinical Trial
Status
- RECRUITING
Central Contacts
- Study Contact
- 844-434-4210
- [email protected]
Study Director
- Janssen Research & Development, LLC Clinical Trial
Eligibility Criteria
Inclusion Criteria:
* Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
* Measurable or evaluable disease.
* (a) Part 1A: JNJ-78278343 + cetrelimab - Prior treatment for mCRPC with at least 1 prior androgen receptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (eg, docetaxel). (b) Part 1C: JNJ-78278343 + docetaxel, Part 1D: JNJ-78278343 + apalutamide, Part 1E: JNJ-78278343 + enzalutamide, Part 1F: JNJ-78278343 + darolutamide, and Part 1G: JNJ-78278343 + abiraterone acetate + prednisone - Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate,). (C) Part 1B: JNJ-78278343 + cabazitaxel - Prior treatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ functions
Exclusion Criteria:
* Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications
* Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (<=) 1 or baseline levels (except for alopecia, vitiligo, Grade <=2 peripheral neuropathy)
* Solid organ or bone marrow transplantation
* Known allergies, or intolerance to any of the components (example, excipients) of JNJ-78278343, cetrelimab (Part 1A), cabazitaxel, (Part 1B), docetaxel (Part 1C), apalutamide (Part 1D), enzalutamide (Part 1E), darolutamide (Part 1F), or abiraterone acetate + prednisone (AAP) (Part 1G)
* Significant infections or serious lung, heart or other medical conditions
Study Plan
JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
EXPERIMENTAL
Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion).
DRUG:
JNJ-78278343Description:
JNJ-78278343 will be administered.DRUG:
CetrelimabDescription:
Cetrelimab will be administered by intravenous infusion.DRUG:
CabazitaxelDescription:
Cabazitaxel will be administered by intravenous infusion.DRUG:
DocetaxelDescription:
Docetaxel will be administered by intravenous infusion.DRUG:
ApalutamideDescription:
Apalutamide will be administered orally.DRUG:
EnzalutamideDescription:
Enzalutamide will be administered orally.DRUG:
DarolutamideDescription:
Darolutamide will be administered orally.DRUG:
Abiraterone acetate plus prednisone (AAP)Description:
Abiraterone acetate plus prednisone (AAP) will be administered orally.
Outcome Measures
Primary Outcome Measures
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
Secondary Outcome Measures
Overall Response Rate (ORR)
Prostate Specific Antigen (PSA) Response Rate
Radiographic Progression-free Survival (rPFS)
Time to Response (TTR)
Duration of Response (DOR)
Timeline
Last Updated
October 24, 2024Start Date
April 19, 2023Today
February 5, 2025Completion Date ( Estimated )
September 1, 2027
Sponsors of this trial
Lead Sponsor
Janssen Research & Development, LLC