Actively Recruiting
A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
300
Participants Needed
15
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying pasritamig (JNJ-78278343) in combination with other treatments for men with metastatic prostate cancer, including both castration-resistant and hormone-sensitive types. The study aims to find the best dose for phase 2 and to assess the safety of pasritamig combined with agents like cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, darolutamide, abiraterone acetate plus prednisone, Lutetium Lu-177 vipivotide tetraxetan, and JNJ-101556143. This is a phase 1b clinical trial focusing on dose escalation and expansion. Participants will first take part in a dose escalation phase where pasritamig doses are gradually increased alongside one of the combination agents to identify the recommended phase 2 regimen. In the following dose expansion phase, participants will receive pasritamig and the combination agent at this recommended dose. Treatments are given either orally or by intravenous infusion depending on the drug involved. Throughout the study, participants will be regularly monitored for safety and side effects, including tracking any dose-limiting toxicities early on and adverse events up to nearly three years. Researchers will also assess cancer responses using measures like prostate specific antigen (PSA) levels, radiographic imaging, and progression-free survival. The total participation time includes treatment and follow-up periods extending up to almost three years to observe how participants respond and tolerate the therapies.
CONDITIONS
Brief Title
A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years or older
- Diagnosed with metastatic castration-resistant prostate cancer (mCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC) as defined by PCWG3 criteria
- Measurable or evaluable disease except for Part 2H
- Prior treatment with at least one androgen receptor pathway inhibitor (ARPI) or chemotherapy as specified for the study parts
- ECOG performance status of 0 or 1
- Adequate organ function confirmed by study assessments
You will not qualify if you...
- Active autoimmune disease within 12 months prior to consent requiring systemic immunosuppressive treatment
- Unresolved toxicity from prior anticancer therapy greater than Grade 1 (except alopecia, vitiligo, or Grade 2 peripheral neuropathy)
- History of solid organ or bone marrow transplant
- Known allergies or intolerance to pasritamig or any of the combination agents used in the study
- Significant infections or serious medical conditions involving the lungs, heart, or other organs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years and 11 months
Participants receive pasritamig (JNJ-78278343) in combination with other agents such as cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, darolutamide, abiraterone acetate plus prednisone, lutetium Lu-177 vipivotide tetraxetan, or JNJ-101556143. The treatment includes a dose escalation phase followed by a dose expansion phase at the recommended dose.
Multiple visits for dosing and assessments during treatment
Trial Site Locations
Total: 15 locations
1
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
2
Start Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
Washington University School Of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
4
Perlmutter Cancer Center at NYU Langone Brooklyn
Brooklyn, New York, United States, 11223
Actively Recruiting
5
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
6
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
7
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
8
Icon Cancer Centre Kurralta Park
Kurralta Park, Australia, 5037
Actively Recruiting
9
Macquarie University
Macquarie University, Australia, 2109
Actively Recruiting
10
Peter MacCallum Cancer Centre
Melbourne, Australia, 3000
Actively Recruiting
11
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Actively Recruiting
12
Hosp Univ Vall D Hebron
Barcelona, Spain, 8035
Actively Recruiting
13
Hosp Univ Fund Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
14
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
15
Hosp Univ Hm Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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