A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

Primary Objective

The purpose of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 (Part 1: dose escalation) and further evaluate the safety at RP2Rs (Part 2: dose expansion) in participants with advanced prostate cancer.

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Description

You are being asked to be in this research study because you have metastatic castration-resistant prostate cancer (mCRPC). This study plans to learn more about whether JNJ-87189401 given in combination with JNJ78278343 in patients with mCRPC can cause side effects, and to find doses of the two drugs when given in combination. Side effects are unexpected or unwanted reactions from receiving the study drugs. Additionally, the study will look at how long JNJ-87189401 and JNJ-78278343 stay in your body, how they act on your body, and how your body responds to them. JNJ-87189401 and JNJ-78278343 are investigational drugs. “Investigational” means that the study drugs has not been approved by the U.S. Food and Drug Administration (FDA).

Details
Age
Adult
Eligibility
Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Locations

CTRC Inpatient
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Laura Graham

Laura Graham

Study ID

Protocol Number: 23-1990

More information available at ClinicalTrials.gov: NCT06095089

Categories

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