JNJ-78278343 for Prostate Cancer

Recruiting at 23 trial locations

Overseen By Study Contact

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must be taking: Androgen deprivation therapy

Must not be taking: Immunosuppressants, Live vaccines

Disqualifiers: CNS involvement, Autoimmune, Heart diseases, others

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

Compensation: Varies

Number of Visits: Unknown

216 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You will need to stop any other anticancer treatments at least 2 weeks before starting the study drug. If you are on medications that suppress the immune system, you must stop them 3 days before the first dose. The protocol does not specify about other medications, so it's best to discuss with the study team.

What is the purpose of this trial?

This trial tests a new medicine that helps immune cells find and kill advanced prostate cancer cells. It is for patients whose cancer has spread and does not respond to usual treatments. The medicine works by linking immune cells to cancer cells, prompting an immune attack on the cancer.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for men with advanced prostate cancer that has spread, who have already tried at least one type of hormone therapy or chemotherapy. They should be relatively healthy and active (ECOG status 0-1), not have major heart issues, clotting diseases, infections like hepatitis B/C or HIV, autoimmune diseases, lung problems, or any other cancers in the last two years.

Inclusion Criteria

I am fully active or can carry out light work.

I have not taken any cancer treatments for at least 2 weeks.

My prostate cancer has spread to other parts of my body.

Exclusion Criteria

I have an ongoing hepatitis B or C infection.

I have had a solid organ or bone marrow transplant.

I have not been diagnosed with any cancer other than prostate cancer in the last 2 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of JNJ-78278343 to determine the recommended phase 2 dose(s) (RP2Ds)

Up to 1 year and 10 months

Dose Expansion

Participants receive JNJ-78278343 at the recommended phase 2 dose(s) determined in Part 1

Up to 1 year and 10 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• JNJ-78278343

Trial Overview The study is testing JNJ-78278343's optimal dose for safety and effectiveness in two parts: first finding the right dose (Dose Escalation) and then confirming its safety at this dose level (Dose Expansion).

Participant Groups

Group I: JNJ-78278343 Experimental Treatment 1 Intervention

Participants will receive JNJ-78278343. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by the study evaluation team (SET) in Part 1 (dose escalation). In Part 2 (dose expansion), participants will receive JNJ-78278343 at recommended phase 2 dose (RP2D) as determined in Part 1.

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