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RecruitingLast updated:15 August 2023

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.

Treatment Type

Systemic therapy (chemotherapy, hormone therapy or immunotherapy)

Age

People18+

Phase

I

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Trial Identifiers

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Commercial 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

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

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

Clinical trials have complex eligibility criteria.

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