JNJ-78278343 for Prostate Cancer
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.12345
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.12346
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of JNJ-78278343 to determine the recommended phase 2 dose(s) (RP2Ds)
Dose Expansion
Participants receive JNJ-78278343 at the recommended phase 2 dose(s) determined in Part 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
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 still on study treatment (i.e., who are in Treatment Phase) at the time of the long term extension (LTE) will continue to receive study treatment until they reach a reason for discontinuation of treatment or until further notification by the sponsor of a different means for continued supply of study treatment, whichever occurs first.
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
Citations
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.
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).
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.
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.pdfPhase 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-mcrpcPasritamig Displays Safety, Durable Disease Control in ...
Pasritamig was safe and produced durable responses in heavily pretreated metastatic castration-resistant prostate cancer.
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