Pasritamig + JNJ-86974680 for Prostate Cancer

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must be taking: GnRH analogs

Disqualifiers: Active infection, Brain metastases, others

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose of two treatments, Pasritamig and JNJ-86974680 (an experimental treatment), for advanced prostate cancer and to assess the safety and effectiveness of this dose. It consists of two parts: first, identifying the correct dose, and then testing that dose to evaluate its efficacy against cancer. This trial may suit individuals with advanced prostate cancer that has spread to bones or lymph nodes and who are already undergoing hormone therapy. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must continue any ongoing androgen deprivation therapy throughout the treatment phase.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Pasritamig may help treat prostate cancer and is generally well-tolerated by patients with advanced stages of the disease. Some early reports suggest it might be effective against cancer cells.

In past studies, only a few participants stopped treatment due to side effects, indicating that most people manage the treatment without major issues.

The combination of Pasritamig with JNJ-86974680 is still under investigation, so information about its safety remains limited. However, since Pasritamig alone is usually well-tolerated, researchers hope the combination will also be safe for most people. As the study progresses, more details about the safety of this combination will become available. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Pasritamig and JNJ-86974680 for prostate cancer because they represent a novel approach in cancer treatment. Unlike standard therapies such as hormone therapy or chemotherapy, these drugs work together to target specific pathways that may improve treatment outcomes. Pasritamig potentially enhances the immune system's ability to fight cancer, while JNJ-86974680 aims to disrupt tumor growth directly. This combo could offer a more targeted and possibly more effective treatment with fewer side effects compared to traditional options.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that combining Pasritamig and JNJ-86974680 yields promising results for treating prostate cancer. In this trial, participants will receive both drugs to determine the recommended phase 2 combination dose (RP2CD) regimen and confirm safety and anti-tumor activity. Pasritamig, a special type of antibody, helps the immune system target cancer cells more effectively. Early findings suggest that patients tolerate this combination well, experiencing minimal side effects. Overall, the initial data supports the potential of this combination to effectively combat prostate cancer. ^{1 2 3 5 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 who have a PSA level of at least 2 ng/mL, measurable or evaluable disease, and are in good physical condition (ECOG status of 0 or 1). They must have adenocarcinoma but not primary small cell or neuroendocrine carcinoma. Participants should have metastatic castration-resistant prostate cancer without visceral organ metastasis and be on ongoing medical castration.

Inclusion Criteria

I am fully active or can carry out light work.

My prostate cancer has spread to bones or lymph nodes but not to organs like the liver or lungs.

I have undergone orchiectomy or am on hormone therapy for prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding

Participants receive pasritamig in combination with JNJ-86974680 to determine the recommended phase 2 combination dose (RP2CD)

Up to Day 22

Dose Expansion

Participants receive pasritamig in combination with JNJ-86974680 at the RP2CD to confirm safety and anti-tumor activity

Up to 1 year 2 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-86974680
• Pasritamig

Trial Overview

The study is testing the combination of two drugs: Pasritamig and JNJ-86974680. The first part determines the best dose to use together, while the second part checks how safe and tolerable this combined dose is for treating advanced prostate cancer.

How Is the Trial Designed?

Group I: Part 2: Dose Expansion Experimental Treatment 2 Interventions

Participants will receive pasritamig in combination with JNJ-86974680 at the RP2CD as determined in Part 1 of the study to confirm the safety and anti-tumor activity.

Group II: Part 1: Dose Finding Experimental Treatment 2 Interventions

Participants will receive pasritamig in combination with JNJ-86974680 to determine the recommended phase 2 combination dose (RP2CD) regimen.

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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07319871

A Study of Pasritamig (JNJ-78278343) in Combination With ...

The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of Pasritamig in combination with JNJ-86974680 in ...

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 ...

Pasritamig appears well-tolerated and exhibits a promising antitumor activity in patients with metastatic castration-resistant prostate cancer (mCRPC).

3.

withpower.com

withpower.com/trial/phase-1-prostatic-neoplasms-11-2025-92184

Pasritamig + JNJ-86974680 for Prostate Cancer

The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of Pasritamig in combination with JNJ-86974680 in Part 1 (Dose ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40450573/

Pasritamig, a First-in-Class, Bispecific T-Cell Engager ...

We report phase I trial results for pasritamig, a first-in-class, T-cell-engaging bispecific antibody targeting human kallikrein 2 (KLK2) expressed on the ...

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 ...

metastatic prostate cancer. N Engl J Med 2019;381(26):2506-2518. CRS ... Pasritamig Achieved Rapid and Deep Prostate-Specific Antigen Responses.

6.

asco.org

asco.org/abstracts-presentations/243849

Phase 1 study results of JNJ-78278343 (pasritamig) in ...

Phase 1 study results of JNJ-78278343 (pasritamig) in metastatic castration-resistant prostate cancer (mCRPC). ; TRAEs leading to treatment discontinuation, n ...