JNJ-78278343 + JNJ-95298177 for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment combination for individuals with metastatic castration-resistant prostate cancer, a type of prostate cancer that has spread and no longer responds to hormone therapy. The main goal is to determine the optimal dose of two experimental drugs, JNJ-78278343 and JNJ-95298177, and assess their safety and effectiveness. The trial seeks participants diagnosed with this specific cancer type who have previously undergone hormone therapy or surgery to reduce male hormone levels. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop taking my current medications for the trial?
The trial requires that you stop taking any anti-cancer or investigational agents at least 14 days before starting the study treatment. Specific treatments like T-cell redirecting therapy, immune checkpoint inhibitors, and others have longer required periods without use before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the drugs JNJ-78278343 and JNJ-95298177 are being tested together to determine the optimal dose for treating prostate cancer that has spread and does not respond to hormone therapy. The safety of this combination for people is still under investigation. This is a Phase 1 trial, marking the first time these drugs are tested in humans. The primary goal of this phase is to assess the treatment's safety and identify potential side effects. Although detailed safety information is not yet available, Phase 1 trials are designed to closely monitor participants and detect any adverse effects. If these drugs had prior approval for other conditions, it might provide more insight into their safety, but that information is currently unclear.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments JNJ-78278343 and JNJ-95298177 for prostate cancer because they represent a novel approach compared to the traditional hormone therapy and chemotherapy options. Unlike standard treatments that typically focus on reducing androgen levels or blocking androgen receptors, JNJ-78278343 and JNJ-95298177 work together to potentially enhance the immune system's ability to target and destroy cancer cells. This combination could offer a new mechanism of action that improves anti-tumor activity and safety, bringing hope for more effective and targeted therapy for patients.
What evidence suggests that this trial's treatments could be effective for metastatic castration-resistant prostate cancer?
Research shows that combining two treatments, JNJ-78278343 (Pasritamig) and JNJ-95298177, holds promise for treating advanced prostate cancer that no longer responds to hormone therapy. This trial will administer the combination to participants to evaluate its safety and anti-tumor activity. Pasritamig has generally been safe, with most patients not experiencing serious side effects. This treatment activates T-cells, key players in the immune system, to target and attack cancer cells. Early results suggest this method might slow down or reduce the cancer, but further research is needed to confirm these findings.12456
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 metastatic castration-resistant prostate cancer (mCRPC). Participants must have a PSA level of at least 2 ng/mL, measurable or evaluable disease, and be in good physical condition (ECOG status of 0 or 1). Only adenocarcinoma of the prostate is allowed; other types like small cell carcinoma are excluded. Men must have had an orchiectomy or be on ongoing androgen deprivation therapy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Confirmation
Participants receive JNJ-78278343 in combination with JNJ-95298177 in a dose de-escalation schedule to determine the recommended phase 2 combination dose (RP2CD)
Dose Expansion
Participants receive JNJ-78278343 in combination with JNJ-95298177 at the RP2CD to confirm safety and anti-tumor activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- JNJ-78278343
- JNJ-95298177
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