KLK2-comPAS_78278343PCR3001
Research type
Research Study
Full title
A Phase 3 Randomized double-blinded, placebo-controlled Study of JNJ-78278343, T-Cell redirecting agent targeting Human Kallikrein 2 with Best Supportive Care (BSC) Versus Placebo with BSC for Metastatic Castration-Resistant Prostate Cancer_KLK2 comPAS_78278343PCR3001
IRAS ID
1012341
Contact name
Elena Bolanos Cascales
Contact email
Sponsor organisation
Janssen-Cilag International NV
ISRCTN Number
ISRCTN21855023
Research summary
This is a randomised, double-blind, placebo-controlled, multinational, Phase 3 study in adult participants with metastatic castration-resistant prostate cancer (mCRPC) in the late-line setting. The purpose of this study is to understand if the study treatment (pasritamig) added to best supportive care (BSC; including radiation, steroids, pain medication, or medications to strengthen the bones) for mCRPC will work better than the best supportive care alone.
Prostate cancer is known to have high levels of a protein called KLK2. Pasritamig is an antibody-like drug that is designed to attach to T cells (part of a type of white blood cells in the immune system) and to KLK2 on cancer cells. Pasritamig is administered intravenously (into a vein).
Participants will be randomly allocated (two to one) to receive either pasritamig and BSC (Arm A), or a placebo and BSC (Arm B).
The study will consist of a Screening phase of up to 28-days, a Treatment phase running from the start of any study treatment (pasritamig or matching placebo) until the study treatment is discontinued, an End of Treatment (EoT) visit, and a Follow-up phase. If applicable, there may also be an extension phase, as described in the study protocol.
REC name
London - Central Research Ethics Committee
REC reference
25/LO/0606
Date of REC Opinion
26 Sep 2025
REC opinion
Further Information Favourable Opinion