InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

RecruitingLast updated: 2 February 2024

This study aims to identify the recommended dose level, and understand the effectiveness, of a new anti-cancer drug when given in addition to immunotherapy (cetrelimab) in people with metastatic castration-resistant prostate cancerA Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer

Clinical summary

Summary

This study has two parts. In Part 1 (dose escalation), participants will receive the new experimental drug (JNJ-78278343) in combination with immunotherapy (Cetrelimab). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 dose (RP2D) is established. In Part 2 (dose expansion), participants will receive the combination treatment of Cetrelimab JNJ-78278343 at the dose level determined in Part 1.

Conditions

This trial is treating patients with metastatic castration-resistant prostate cancer (mCRPC)

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer

Eligibility

Inclusion

  • Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
  • Measurable or evaluable disease.
  • Prior treatment for mCRPC with at least 1 prior novel androgen receptor-targeted therapy (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (eg, docetaxel)
  • 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, hypersensitivity, or intolerance to any of the components (eg, excipients) of JNJ-78278343 or cetrelimab
  • Significant infections or serious lung, heart or other medical conditions

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

Exclusion

  • 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.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.