A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, o

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

Last Updated May 14, 2025

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CR109321

OVERVIEW

Sexes Eligible for Study
male
Age
18+ years
Phase
phase 1
Sites
11 Sites
Status

Recruiting

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).

CONDITIONS

Metastatic Castration-resistant Prostate Neoplasms

ELIGIBILITY

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 non-castrate levels of testosterone (greater than [>] 150 ng/ deciliter [dL]) and a minimum PSA of 2 ng/milliliter [mL]; (b) Metastatic disease documented by greater than equal to (>=) 1 bone lesion(s) on technetium-99m (99m^Tc) bone scan. No definitive evidence of metastatic visceral disease
* 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

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Australia

Country (2)	City or Province (11)	Status
United States	Sarasota Florida Cancer Specialists	RECRUITING
United States	Grand Rapids Start Midwest	RECRUITING
Australia	Macquarie University Macquarie University	RECRUITING
Australia	Melbourne Peter MacCallum Cancer Centre	RECRUITING
Australia	Woolloongabba Princess Alexandra Hospital	RECRUITING
United States	Saint Louis Washington University School Of Medicine	RECRUITING
United States	New York NYU Langone Health	RECRUITING
United States	Philadelphia Sidney Kimmel Cancer Center - Jefferson Health	RECRUITING
United States	Brooklyn Perlmutter Cancer Center at NYU Langone Brooklyn	RECRUITING
United States	Mineola Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island	RECRUITING
Australia	Kurralta Park Icon Cancer Centre Kurralta Park	RECRUITING

Geo Locations

27.33643, -82.53065

42.96336, -85.66809

-33.7738237, 151.1126498

-37.814, 144.96332

-27.48855, 153.03655

38.62727, -90.19789

40.71427, -74.00597

39.95233, -75.16379

40.6501, -73.94958

40.74927, -73.64068

-34.95142, 138.56702

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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