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RecruitingLast updated: 12 January 2026

KLK2-comPAS: This trial is recruiting people with metastatic castration-resistant prostate cancer (mCRPC) to evaluate whether immunotherapy combined with best supportive care is more effective than placebo combined with best supportive careA Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

KLK2-comPAS

Clinical summary

Summary

The purpose of this study is to evaluate the overall survival (length of time from the start of the study to date of death from any cause) for pasritamig immunotherapy in combination with best supportive care, as compared to placebo with best supportive care, in people with metastatic castration-resistant prostate cancer (mCRPC). This is a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies.

To be eligible for this trial, you should have had all life-prolonging treatments for which you are eligible and have access to.

Pasritamig is also known as JNJ-78278343 and is a T-cell redirecting agent that binds to KLK2 which is a prostate-specific antigen found on prostate cancer cells, so it can deliver targeted immunotherapy.

Eligible participants will be randomly allocated (by chance) to one of two arms:

  • Experimental Arm: Pasritamig intravenous (IV) infusion plus best supportive care
  • Placebo Comparator Arm: Placebo IV infusion plus best supportive care.

Best supportive care will be administered as per physician, and may be palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures.

Conditions

This trial is treating people with metastatic castration-resistant prostate cancer who have had all life-prolonging therapies for which they are eligible and have access

Eligibility

Inclusion

  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs at the time of screening
  • PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL) at screening
  • In the opinion of the investigator, the next best treatment option is a clinical trial
  • Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following:

Androgen-receptor pathway inhibitor (ARPI): Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI

Taxanes: Should have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if:

  1. Cabazitaxel is not available
  2. The participant's physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period.

Radioligand therapy: Should have been previously treated with at least 1 dose of Prostate-specific membrane antigen (PSMA)-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies:

  1. PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated.
  2. The participant's physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy.

Polyadenosine diphosphate-ribose polymerase inhibitors (PARPi): Should have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available

  • Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog [agonist or antagonist]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Participants are eligible if they have the following values:

A) eGFR >= 30 milliliters per minute (mL/min) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (<=) 5 times the Upper Limit of Normal (ULN) C) Serum total bilirubin <= 3 * ULN D) Absolute neutrophil count (ANC) >= 1.0 *10^9/per liter (L) E) Hemoglobin >= 8.0 grams per deciliter (g/dL) F) Platelet count >= 75 * 109/L

Exclusion

  • Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade <= 2) deep vein thrombosis is not exclusionary
  • Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus)
  • Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (>2 liters per minute (L/min) by nasal cannula) to maintain adequate oxygenation
  • Prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)
  • Any of the following within 6 months prior to first dose of study treatment:

A) Myocardial infarction B) Severe or unstable angina C) Clinically significant ventricular arrhythmias D) Congestive heart failure (New York Heart Association class II to IV) E) Transient ischemic attack F) Cerebrovascular accident

- Prior treatment with any CD3-directed therapy

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT07164443 *
  • 2025-520927-26-00 *
  • 78278343PCR3001; 78278343PCR3001

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer

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