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

NCT ID: NCT05818683

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-26

Study Completion Date

2027-09-01

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

JNJ-78278343

Intervention Type DRUG

JNJ-78278343 will be administered.

Cetrelimab

Intervention Type DRUG

Cetrelimab will be administered by intravenous infusion.

Cabazitaxel

Intervention Type DRUG

Cabazitaxel will be administered by intravenous infusion.

Docetaxel

Intervention Type DRUG

Docetaxel will be administered by intravenous infusion.

Apalutamide

Intervention Type DRUG

Apalutamide will be administered orally.

Enzalutamide

Intervention Type DRUG

Enzalutamide will be administered orally.

Darolutamide

Intervention Type DRUG

Darolutamide will be administered orally.

Abiraterone acetate plus prednisone (AAP)

Intervention Type DRUG

Abiraterone acetate plus prednisone (AAP) will be administered orally.

Interventions

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JNJ-78278343

JNJ-78278343 will be administered.

Intervention Type DRUG

Cetrelimab

Cetrelimab will be administered by intravenous infusion.

Intervention Type DRUG

Cabazitaxel

Cabazitaxel will be administered by intravenous infusion.

Intervention Type DRUG

Docetaxel

Docetaxel will be administered by intravenous infusion.

Intervention Type DRUG

Apalutamide

Apalutamide will be administered orally.

Intervention Type DRUG

Enzalutamide

Enzalutamide will be administered orally.

Intervention Type DRUG

Darolutamide

Darolutamide will be administered orally.

Intervention Type DRUG

Abiraterone acetate plus prednisone (AAP)

Abiraterone acetate plus prednisone (AAP) will be administered orally.

Intervention Type DRUG

Other Intervention Names

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JNJ-63723283

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Florida Cancer Specialists

Sarasota, Florida, United States

Site Status RECRUITING

Start Midwest

Grand Rapids, Michigan, United States

Site Status RECRUITING

Washington University School Of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Perlmutter Cancer Center at NYU Langone Brooklyn

Brooklyn, New York, United States

Site Status RECRUITING

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, United States

Site Status RECRUITING

NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Sidney Kimmel Cancer Center - Jefferson Health

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Icon Cancer Centre Kurralta Park

Kurralta Park, , Australia

Site Status RECRUITING

Macquarie University

Macquarie University, , Australia

Site Status RECRUITING

Peter MacCallum Cancer Centre

Melbourne, , Australia

Site Status RECRUITING

Princess Alexandra Hospital

Woolloongabba, , Australia

Site Status RECRUITING

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Site Status RECRUITING

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Hosp Univ Hm Sanchinarro

Madrid, , Spain

Site Status RECRUITING

Countries

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South Korea United States Australia Spain

Central Contacts

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Study Contact

Role: CONTACT

Phone: 844-434-4210

Email: [email protected]

Other Identifiers

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78278343PCR1003

Identifier Type: OTHER

Identifier Source: secondary_id

2022-503132-14-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR109321

Identifier Type: -

Identifier Source: org_study_id