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NCT05818683RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
300 (estimated)
First submitted
6 Apr 2023
Start date
26 Apr 2023
Primary completion date
31 Aug 2027
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05818683
EU CT number
2022-503132-14-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 300
  • From 26 Apr 2023 to the primary completion date, 31 Aug 2027
  • 15 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Icon Cancer Centre Kurralta Park
Coordinator of this site? Confirm its status
AdelaideAustraliaRecruiting
Macquarie University
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Macquarie ParkAustraliaRecruiting
Peter MacCallum Cancer Centre
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MelbourneAustraliaRecruiting
Princess Alexandra Hospital
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WoolloongabbaAustraliaRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario HM Sanchinarro
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
Perlmutter Cancer Center at NYU Langone Brooklyn
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BrooklynUnited StatesRecruiting
START | Midwest
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Grand RapidsUnited StatesRecruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
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MineolaUnited StatesRecruiting
NYU Langone Health
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New YorkUnited StatesRecruiting
Sidney Kimmel Cancer Center - Jefferson Health
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PhiladelphiaUnited StatesRecruiting
Florida Cancer Specialists
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SarasotaUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.