JNJ-70218902 for Advanced Stage Cancer

Recruiting at 14 trial locations

Overseen By Study Contact

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must be taking: GnRH analogs

Must not be taking: Anticancer treatments

Disqualifiers: Brain metastases, Transplantation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

82 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing JNJ-70218902, a drug that helps the immune system target and destroy cancer cells, in adult men with advanced prostate cancer that doesn't respond to usual treatments.

Do I need to stop my current medications for the trial?

The trial requires that if you are on gonadotropin-releasing hormone therapy, you must continue it throughout the study. For other medications, the protocol does not specify if you need to stop them.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for adults with advanced solid tumors, specifically metastatic castration-resistant prostate cancer. Participants must have a good performance status (able to carry out daily activities), proper organ function, and if applicable, ongoing hormone therapy. They should have tried at least one prior cancer treatment but can't join if they still have significant side effects from past treatments or certain serious health conditions.

Inclusion Criteria

I am on GnRH therapy and started it before the study drug.

I am fully active or can carry out light work.

My cancer can be measured or seen on tests.

Exclusion Criteria

I am not currently using any other cancer treatments or experimental drugs.

I have cancer that has spread to my brain.

Side effects from my previous cancer treatments have mostly gone, except for hair loss or skin color changes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part 1: Dose Escalation

Participants receive JNJ-70218902 with dose levels escalated sequentially to determine the recommended Phase 2 Dose (RP2D)

21 days

Treatment - Part 2: Dose Expansion

Participants receive JNJ-70218902 at the RP2D determined in Part 1

Up to 2.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2.5 years

Treatment Details

Interventions

• JNJ-70218902

Trial Overview The study is testing JNJ-70218902 to find the safest and most effective dose for Phase 2 trials. Part 1 of the study will determine the maximum tolerated dose and Part 2 will assess safety at this recommended dose in participants with advanced stage solid tumors.

Participant Groups

Group I: Part 2: Dose Expansion Experimental Treatment 1 Intervention

Participants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1.

Group II: Part 1: Dose Escalation Experimental Treatment 1 Intervention

Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-70218902. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires