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NCT05818683From ClinicalTrials.govRecruiting

A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

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

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

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
300
Started
26 April 2023
Main results due
31 August 2027
Study sites
15
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Men only.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility 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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(15)

  • Florida Cancer Specialists

    Sarasota, Florida, United States

    Recruiting

  • Start Midwest

    Grand Rapids, Michigan, United States

    Recruiting

  • Washington University School Of Medicine

    St Louis, Missouri, United States

    Recruiting

  • Perlmutter Cancer Center at NYU Langone Brooklyn

    Brooklyn, New York, United States

    Recruiting

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

    Mineola, New York, United States

    Recruiting

  • NYU Langone Health

    New York, New York, United States

    Recruiting

  • Sidney Kimmel Cancer Center - Jefferson Health

    Philadelphia, Pennsylvania, United States

    Recruiting

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, Australia

    Recruiting

  • Macquarie University

    Macquarie University, Australia

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Australia

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Australia

    Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, Spain

    Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, Spain

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, Spain

    Recruiting

  • Hosp Univ Hm Sanchinarro

    Madrid, Spain

    Recruiting

Showing 15 of 15 sites. 15 of the 15 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05818683. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer | Trialion