Recruiting
Phase 1

JNJ-78278343 & Combination Agent

Sponsor:

Janssen Research & Development, LLC

Code:

NCT05818683

Conditions

Metastatic Castration-resistant Prostate Neoplasms

Metastatic Hormone-sensitive Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pasritamig

Cetrelimab

Cabazitaxel

Docetaxel

Apalutamide

Study Details

Brief 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).

Conditions

Metastatic Castration-resistant Prostate Neoplasms

Metastatic Hormone-sensitive Prostate Cancer

Study ID

NCT05818683

Start date

Apr 26, 2023

Status verified date

Aug, 2026

Completion date

May 23, 2028

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 (apalutamide): metastatic hormone-sensitive prostate cancer(mHSPC) with PSA greater than (>) 0.2 ng/mL on 6 to 24 months of treatment with a next generation ARPI (apalutamide, enzalutamide, darolutamide, or abiraterone)
  • Measurable or evaluable disease, except for Part 2H
  • (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, 2G (AAP), and Part 1K \& 2K (JNJ-101556143)- 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 may have received up to 6 cycles of docetaxel. The last dose of docetaxel must be administered at least 2 months prior to enrollment (f) Parts 1I, 1J, 2I \& 2J (lutetium Lu-177 vipivotide tetraxetan)- Prior treatment with at least 1 ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide). Participant must not have received prior cytotoxic chemotherapy or prior radioligand therapy (RLT) for mCRPC
  • 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 pasritamig, 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), lutetium Lu-177 vipivotide tetraxetan (Parts 1I, 1J, 2I, and 2J), or JNJ-101556143 (Parts 1K \& 2K)
  • Significant infections or serious lung, heart or other medical conditions

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)

Participants will receive pasritamig (JNJ-78278343) and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone, Lutetium Lu-177 vipivotide tetraxetan and JNJ-101556143) during Part 1 (dose escalation). The dose of pasritamig (JNJ-78278343) will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive pasritamig (JNJ-78278343) and combination agent treatment at the putative RP2R in Part 2 (dose expansion).

Interventions

Pasritamig

Pasritamig will be administered.

Cetrelimab

Cetrelimab will be administered by intravenous infusion.

Cabazitaxel

Cabazitaxel will be administered by intravenous infusion.

Docetaxel

Docetaxel will be administered by intravenous infusion.

Apalutamide

Apalutamide will be administered orally.

Enzalutamide

Enzalutamide will be administered orally.

Darolutamide

Darolutamide will be administered orally.

Abiraterone acetate plus prednisone (AAP)

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

Lutetium Lu-177 vipivotide tetraxetan

Lutetium Lu-177 vipivotide tetraxetan will be administered intravenously.

JNJ-101556143

JNJ-101556143 will be administered orally.

Primary outcome measure

  • Part 1: Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Up to 21 days after first dose of combination agent ]
  • Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity [ Time Frame: Up to 2 years 11 months ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Start Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Washington University School Of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Perlmutter Cancer Center at NYU Langone Brooklyn

Recruiting

Brooklyn, New York, United States, 11223

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

Recruiting

Mineola, New York, United States, 11501

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Sidney Kimmel Cancer Center - Jefferson Health

Recruiting

Philadelphia, Pennsylvania, United States, 19107

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.