JNJ-78278343 for Prostate Cancer

Recruiting at 25 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, JNJ-78278343, to treat prostate cancer that has spread to other parts of the body. The goal is to determine the best dose and assess its safety for later research stages. The trial includes individuals who have tried at least one other prostate cancer treatment and can pause other cancer treatments for two weeks before starting the trial. Participants should have had their testicles removed or be receiving ongoing hormone therapy. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that JNJ-78278343 is likely to be safe for humans?

Research shows that JNJ-78278343, also known as pasritamig, is generally well-tolerated by patients with prostate cancer. Studies indicate it has a good safety record, even for those who have undergone many prior treatments. Reports suggest that this treatment might help combat cancer cells. Although specific side effects aren't listed, the emphasis on safety suggests that serious side effects are uncommon. As this is a Phase 1 trial, the primary goal is to ensure the treatment's safety and determine the optimal dose for future studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JNJ-78278343 for prostate cancer because it offers a novel approach compared to traditional treatments like hormone therapy, chemotherapy, and radiation. Unlike these standard options, JNJ-78278343 is designed to escalate dose levels based on individual patient tolerance, potentially minimizing side effects while maximizing effectiveness. Additionally, it aims to target specific cancer pathways more precisely, which could lead to improved outcomes for patients who have not responded well to existing therapies. This personalized dosing strategy and targeted action are what set JNJ-78278343 apart and fuel optimism for its potential benefits.

What evidence suggests that JNJ-78278343 might be an effective treatment for prostate cancer?

Research shows that JNJ-78278343, also known as pasritamig, may help treat prostate cancer. This antibody can attach to both cancer cells and T-cells, aiding the immune system in identifying and destroying cancer cells. Studies have found that pasritamig is generally safe for patients and shows promising results in treating prostate cancer that has spread and no longer responds to hormone therapy. Early findings suggest this treatment might effectively boost the body's immune response to fight cancer. However, more research is needed to fully understand its potential. Participants in this trial will receive JNJ-78278343, with dose levels adjusted based on safety evaluations. ^{1 2 3 4 6}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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. Participants who are receiving benefit, from the treatment will continue to receive the study treatment by entering the long term extension (LTE) phase as per investigator's judgement.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

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

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.5017

Phase 1 study results of JNJ-78278343 (pasritamig) in ... Pasritamig is a first-in-class T-cell-redirecting bispecific antibody that simultaneously binds KLK2 on PC cells and CD3 receptor complexes on T cells.

2. jnj.com jnj.com/media-center/press-releases/johnson-johnson-unveils-first-in-human-results-for-pasritamig-showing-early-anti-tumor-activity-in-prostate-cancer

Pasritamig, a first-in-class bispecific T-cell-engaging ... Pasritamig appears well-tolerated and exhibits a promising antitumor activity in patients with metastatic castration-resistant prostate cancer (mCRPC).

3. urotoday.com urotoday.com/conference-highlights/asco-2025/asco-2025-prostate-cancer/160809-asco-2025-phase-1-study-results-of-jnj-78278343-pasritamig-in-mcrpc.html

Phase 1 Study Results of JNJ-78278343 (Pasritamig) in ... Dr. Baldini reported dose escalation and expansion results from a first-in-human study evaluating pasritamig in patients with mCRPC.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07082920

NCT07082920 | A Study of JNJ-78278343 in Combination ... The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of JNJ-78278343 in combination with JNJ-95298177 in Part 1 (Dose ...

5. jnjmedicalconnect.com jnjmedicalconnect.com/media/attestation/congresses/oncology/2025/am/phase-1-study-results-of-jnj78278343-pasritamig-in-metastatic-castrationresistant-prostate-cancer-mc.pdf

Phase 1 Study Results of Pasritamig (JNJ-78278343) in ... Cabazitaxel versus abiraterone or enzalutamide in metastatic prostate cancer. N Engl J Med 2019;381(26):2506-2518. CRS, cytokine release ...

6. onclive.com onclive.com/view/pasritamig-displays-safety-durable-disease-control-in-heavily-pretreated-mcrpc

Pasritamig Displays Safety, Durable Disease Control in ... Pasritamig was safe and produced durable responses in heavily pretreated metastatic castration-resistant prostate cancer.