JNJ-78278343 + Cetrelimab for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions prior treatment with certain medications, so it's best to discuss your current medications with the trial team.
How is the drug JNJ-78278343 + Cetrelimab unique for prostate cancer treatment?
The drug JNJ-78278343 + Cetrelimab is unique because it combines a novel approach of targeting prostate cancer cells with a bispecific antibody that engages both PSMA on tumor cells and CD3 on T cells, potentially overcoming the immunosuppressive environment of prostate cancer and enhancing the body's immune response against the tumor.12345
What data supports the effectiveness of the drug JNJ-78278343 + Cetrelimab for prostate cancer?
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive JNJ-78278343 and combination agent with dose escalation to determine the recommended phase 2 regimen
Dose Expansion
Participants receive JNJ-78278343 and combination agent at the putative RP2R to assess safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cetrelimab
- JNJ-78278343
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University