Metastatic hormone-resistant prostate cancer is prostate cancer that has spread to other parts of the body and continues to grow despite very low testosterone levels. Although several treatments are available, many men eventually need additional treatment options. Researchers continue to study new therapies that may help control the disease and improve quality of life.
Official Title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Hormone-Resistant Prostate Cancer.
Pasritamig in the Phase 3 KLK2-comPAS Clinical Study
The KLK2-comPAS study is evaluating the investigational treatment pasritamig (JNJ-78278343) together with best supportive care for men with metastatic hormone-resistant prostate cancer. The main goal of the study is to learn whether pasritamig, when given with best supportive care, may help people live longer compared with placebo plus best supportive care. Researchers will also continue to study safety, side effects, and quality of life. How the Therapy Works
Pasritamig is an investigational bispecific antibody. One part attaches to KLK2, a protein found on some prostate cancer cells. The other part attaches to T cells, which help the immune system fight disease. By bringing these cells together, pasritamig may help the immune system recognize and attack prostate cancer cells.
Study Design
This is a Phase 3, randomized, double-blind, placebo-controlled clinical study. Approximately 663 participants are expected to enroll. Two out of every three participants will receive pasritamig plus best supportive care, while one out of every three participants will receive placebo plus best supportive care. Neither participants nor the study team will know which treatment is being received during the study.
Who Can Participate?
Men may qualify if they are 18 years of age or older, have metastatic hormone-resistant prostate cancer, have received prior prostate cancer treatments, and meet all study eligibility requirements. The study team will review medical history, current health, previous treatments, blood tests, imaging scans, and other eligibility criteria.
What Participation May Involve
Participation includes screening, study treatment, and follow-up. Screening takes about four weeks. Study treatment is given by IV infusion. Premedication may be given before treatment to help reduce side effects. The first treatment cycle includes step-up dosing. All participants receive best supportive care. Follow-up visits generally occur every three months after treatment ends.
Participants will be monitored throughout the study. Follow-up may continue after treatment ends so researchers can learn more about long-term outcomes and survival.
Possible Benefits & Risks
Because pasritamig is investigational, it may or may not benefit participants. Possible benefits include slowing cancer growth or helping control the disease. Possible risks include infusion-related reactions, cytokine release syndrome, fatigue, fever, changes in blood test results, and other known or unknown side effects. Participants are monitored closely throughout the study.
Possible side effects of pasritamig may include:
- Infusion-related reactions
- Fever
- Fatigue
- Cytokine release syndrome (CRS)
- Changes in blood test results
- Neurologic side effects
Organization:
Janssen Research & Development, LLC.
https://klk2-compas.clinicaltrials.jnj.com/
ClinicalTrials.gov Information:
- NCT Number: NCT07164443
- Title: A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) (KLK2-comPAS)
Use the “clinical trials glossary” and “dictionary” for words, phrases, and treatments that you may not understand.
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Please Note: This information is provided for educational and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.
GLOSSARY OF TERMS
Click any word to see what it means.
Bispecific antibody
A medicine designed to attach to two different targets at the same time.
Clinical trial
A research study involving people that tests a medicine, treatment, or medical approach.
Cytokine release syndrome
A reaction that can happen when the immune system becomes very active.
Double-blind
Neither you nor your study doctor knows which treatment you are receiving until the study is completed or the information is needed for your safety.
Hormone therapy
Treatment that lowers or blocks hormones that can help prostate cancer grow.
Infusion-related reaction
A reaction that happens during or shortly after an IV infusion.
Investigational medicine
A medicine that is still being studied for the use described in the clinical trial.
IV infusion
A way to give medicine through a needle or small tube placed in a vein.
KLK2
A protein found on some prostate cancer cells.
Metastatic hormone-resistant prostate cancer
Prostate cancer that has spread and continues to grow even when hormone treatment keeps testosterone very low.
Placebo
A treatment that looks like the study medicine but has no active medicine.
Premedication
Medicine given before study treatment to help prevent or reduce side effects.
Quality of Life
A person’s overall well-being, including physical, emotional, and daily life experiences.
Random assignment
Placement into a study group by chance, usually by a computer.
Randomized
You are assigned to a treatment group by chance, not by you or your doctor.
Step-up dosing
Starting with a lower dose and slowly increasing the amount.
Supportive care
Care that helps control symptoms, improve comfort, and support quality of life.
T cell
A white blood cell that helps the immune system respond to disease.
Treatment cycle
A set period during which study treatment and tests take place.
