A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer

Purpose

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).

Conditions

  • Metastatic Castration-resistant Prostate Neoplasms
  • Metastatic Hormone-sensitive Prostate Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Part 1 A-G (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 (apalutamide, enzalutamide, darolutamide, abiraterone acetate + prednisone [AAP]): mCRPC: Histologically confirmed adenocarcinoma of the prostate as defined by PCWG3, with a minimum PSA of 2 nanogram [ng]/milliliter (mL); Part 2H (apalutamide): (a) metastatic hormone-sensitive prostate cancer(mHSPC) with PSA greater than (>) 0.2 ng/mL despite being treated with next generation ARPI (apalutamide, enzalutamide, darolutamide) for between 180 and 365 days (inclusive); (b) Participant may not have progressed radiographically or have PSA progression while receiving androgen deprivation therapy (ADT) and ARPI, as defined by PCWG3 - Measurable or evaluable disease - (a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgen receptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (example, docetaxel). (b) Part 1C and 2C (docetaxel), Part 1D (apalutamide), Part 1E and 2E (enzalutamide), Part 1F and 2F (darolutamide), and Part 1G and 2G (AAP)- Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate). (C) Part 1B and 2B (cabazitaxel) - Prior treatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel. (d) Part 2D (apalutamide) - Prior treatment with at least 1 prior ARPI (e) Part 2H (apalutamide)- Participant must not have received prior cytotoxic chemotherapy - 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 and 2B , docetaxel Part 1C and 2C , apalutamide (Part 1D and 2D and Part 2H), enzalutamide (Part 1E and 2E), darolutamide (Part 1F and 2F), or AAP (Part 1G and 2G) - Significant infections or serious lung, heart or other medical conditions

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) 		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-78278343
    JNJ-78278343 will be administered.
  • Drug: Cetrelimab
    Cetrelimab will be administered by intravenous infusion.
    Other names:
    • JNJ-63723283
  • Drug: Cabazitaxel
    Cabazitaxel will be administered by intravenous infusion.
  • Drug: Docetaxel
    Docetaxel will be administered by intravenous infusion.
  • Drug: Apalutamide
    Apalutamide will be administered orally.
  • Drug: Enzalutamide
    Enzalutamide will be administered orally.
  • Drug: Darolutamide
    Darolutamide will be administered orally.
  • Drug: Abiraterone acetate plus prednisone (AAP)
    Abiraterone acetate plus prednisone (AAP) will be administered orally.

Recruiting Locations

Florida Cancer Specialists
Sarasota 4172131, Florida 4155751 34232

Start Midwest
Grand Rapids 4994358, Michigan 5001836 49546

Washington University School Of Medicine
St Louis 4407066, Missouri 4398678 63110

Perlmutter Cancer Center at NYU Langone Brooklyn
Brooklyn 5110302, New York 5128638 11223

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola 5127134, New York 5128638 11501

NYU Langone Health
New York 5128581, New York 5128638 10016

Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia 4560349, Pennsylvania 6254927 19107

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com