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A Study of Pasritamig for Metastatic Prostate Cancer

This study is looking into a new treatment called Pasritamig (JNJ-78278343) for men with metastatic prostate cancer. This means the cancer has spread to other parts of the body. Researchers are testing Pasritamig by itself and in combination with other approved prostate cancer medicines like Cetrelimab, Cabazitaxel, Docetaxel, and Apalutamide. The main goal is to find the safest and most effective doses of these treatments and to understand any side effects. You may be able to join if you are a man aged 18 or older with metastatic castration-resistant prostate cancer (mCRPC) or metastatic hormone-sensitive prostate cancer. The study plans to enroll about 300 participants, but its current status is unclear.

Study design
This study is an interventional trial, meaning participants will receive specific treatments. It aims to identify recommended doses and evaluate safety in two parts: dose escalation and dose expansion.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events (side effects) for up to 2 years and 11 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05818683

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~300 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:PasritamigCetrelimabCabazitaxelDocetaxelApalutamideEnzalutamide

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Measured over Up to 21 days after first dose of combination agent
+1 more outcome measured

Conditions

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

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Where it's being run

15 sites across 7 states
Australia4
Spain4
New York3
Florida1
Michigan1
Missouri1
Pennsylvania1

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 trial measures

  • Part 1: Number of Participants With Dose Limiting Toxicity (DLT)Up to 21 days after first dose of combination agent

    DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.

  • Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by SeverityUp to 2 years 11 months

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.