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Combining JNJ-78278343 with other treatments for advanced prostate cancer

A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer

PHASE1 · Janssen Research & Development, LLC · NCT05818683

This study is testing a new treatment called JNJ-78278343 combined with other therapies to see if it helps people with advanced prostate cancer feel better and stay safe.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexMale
SponsorJanssen Research & Development, LLC (industry)
Drugs / interventionscetrelimab, chemotherapy, prednisone
Locations15 sites (Sarasota, Florida and 14 other locations)
Trial IDNCT05818683 on ClinicalTrials.gov

What this trial studies

This study aims to identify the recommended phase 2 regimens of JNJ-78278343 in combination with either Cetrelimab, taxane chemotherapy, or androgen receptor pathway inhibitors for patients with metastatic castration-resistant prostate cancer. The trial is divided into two parts: the first part focuses on dose escalation to determine the optimal dosing, while the second part assesses the safety of the identified regimens. Participants will receive one of the combination treatments to evaluate its effectiveness and safety profile.

Who should consider this trial

Good fit: Ideal candidates include men with metastatic castration-resistant prostate cancer who have confirmed adenocarcinoma of the prostate and meet specific criteria regarding prior treatments and disease characteristics.

Not a fit: Patients with non-metastatic prostate cancer or those who do not meet the specific eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new effective treatment options for patients with advanced prostate cancer.

How similar studies have performed: Other studies have shown promise in using combination therapies for advanced prostate cancer, suggesting that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Sarasota, Florida and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Metastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.