What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including androgen deprivation therapy (ADT), chemotherapy, and newer hormonal agents like enzalutamide and abiraterone, have various side effects. ADT can cause hot flashes, decreased libido, fatigue, and osteoporosis. Chemotherapy, particularly with taxanes like docetaxel, can lead to neuropathy, alopecia, and myelosuppression. Enzalutamide and abiraterone may cause fatigue, hypertension, and increased risk of cardiovascular events. T-cell-redirecting agents, similar to JNJ-78278343, may have immune-related side effects such as cytokine release syndrome and neurotoxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for advanced prostate cancer, including androgen receptor inhibitors like enzalutamide, apalutamide, and darolutamide, which block androgen receptor signaling. Additionally, abiraterone, an androgen biosynthesis inhibitor, has been approved for use with prednisone. Immunotherapy options include sipuleucel-T, a dendritic cell vaccine, and pembrolizumab for tumors with specific genetic markers. Radioligand therapy with lutetium Lu 177 vipivotide tetraxetan has also been approved for PSMA-positive metastatic CRPC. These treatments offer various mechanisms of action, targeting different pathways involved in prostate cancer progression.

What other types of research exist?

Promising novel alternatives for prostate cancer treatment in 2024 include: 1) Relugolix, an oral GnRH antagonist, which offers a new approach to hormonal therapy. 2) Niraparib combined with abiraterone for patients with homologous recombination repair (HRR) deficiencies, as shown in the MAGNITUDE trial. 3) Olaparib combined with abiraterone, which has demonstrated significant prolongation in radiographic progression-free survival in the PROPEL trial. 4) Enzalutamide, apalutamide, and darolutamide, which are androgen receptor antagonists with distinct efficacy and safety profiles. These alternatives provide various mechanisms of action and potential benefits for different patient subgroups.

← Back to Search

CAR T-cell Therapy

JNJ-78278343 for Prostate Cancer

Phase 1

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Concurrent use of any other anticancer treatment must be discontinued for at least 2 weeks before the first dose of study drug

Must not have

Active or chronic hepatitis B or hepatitis C infection

Solid organ or bone marrow transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year and 10 months

Awards & highlights

Summary

This trial is testing a new drug to see what dose is safe and effective.

Who is the study for?

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.Check my eligibility

What is being tested?

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).See study design

What are the potential side effects?

While specific side effects are not listed here, similar treatments often cause immune reactions since they target proteins on cancer cells which can affect normal cells too. This might lead to flu-like symptoms, fatigue, skin reactions among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Select...

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

Select...

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

Select...

My cancer can be measured or seen on tests.

Select...

I have had treatment with a specific hormone therapy or chemotherapy before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have an ongoing hepatitis B or C infection.

Select...

I have had a solid organ or bone marrow transplant.

Select...

I currently have an infection.

Select...

My cancer has spread to my brain or spinal cord.

Select...

I have been treated with a therapy targeting KLK2 before.

Select...

I have a serious lung condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year and 10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year and 10 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year and 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1 and 2: Number of Participants With AEs by Severity

Part 1 and 2: Number of Participants With Adverse Events (AEs)

Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)

Secondary outcome measures

Duration of Response (DOR)

Number of Participants With Anti-JNJ-78278343 Antibodies

Objective Response Rate (ORR)

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: JNJ-78278343Experimental Treatment1 Intervention

Participants will receive JNJ-78278343 either subcutaneously (SC injection or SC infusion) or intravenous (IV) infusion. 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 either SC or IV at recommended phase 2 dose (RP2D) as determined in Part 1.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments primarily target the androgen receptor pathway, immune system, or specific cancer cell markers. Androgen deprivation therapy (ADT) reduces testosterone levels to slow cancer growth. Immunotherapies, such as sipuleucel-T, enhance the body's immune response against cancer cells. Novel agents like JNJ-78278343, a T-cell-redirecting agent, target specific proteins on cancer cells to direct the immune system to attack them. Understanding these mechanisms helps tailor treatments to individual patients, potentially improving outcomes and minimizing side effects.

Tools for predicting patient-reported outcomes in prostate cancer patients undergoing radical prostatectomy: a systematic review of prognostic accuracy and validity.Active surveillance for low-risk prostate cancer.Overview of international collaborative group prostate cancer trials.