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Monoclonal Antibodies

JNJ-78278343 + Cetrelimab for Prostate Cancer

Phase 1

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years 11 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is researching the safe dose of two new drugs for cancer treatment.

Who is the study for?

This trial is for men with advanced prostate cancer that's resistant to hormone therapy and has spread. They should have tried at least one other treatment like abiraterone or chemotherapy, be relatively healthy (ECOG status of 0 or 1), and have adequate organ function. Men can't join if they've had recent autoimmune disease treatments, unresolved side effects from previous cancer therapies (except minor nerve damage or hair loss), transplants, serious infections, heart/lung problems, or allergies to the drugs being tested.

What is being tested?

The study is testing a combination of two drugs: JNJ-78278343 and Cetrelimab in patients with metastatic castration-resistant prostate cancer. The first part will find the best doses to use while checking safety. The second part will see how safe these doses are when more people take them.

What are the potential side effects?

Possible side effects include reactions related to the immune system since both drugs work by boosting it—this could lead to inflammation in different parts of the body. There might also be typical drug infusion reactions as well as general fatigue and issues affecting organs due to increased immune activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years 11 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years 11 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 11 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity

Part 1: Number of Participants With Dose Limiting Toxicity (DLT)

Secondary study objectives

Duration of Response (DOR)

Overall Response Rate (ORR)

Prostate Specific Antigen (PSA) Response Rate

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)Experimental Treatment8 Interventions

Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetrelimab

2022

Completed Phase 1

~20

Cabazitaxel

2014

Completed Phase 3

~1290