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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

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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.

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Recruiting hospitals

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