A Phase 1b Study of Pasritamig (JNJ-78278343), a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-86974680, an A2a Receptor (A2aR) Antagonist, for Prostate Cancer
Summary
The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of Pasritamig in combination with JNJ-86974680 in Part 1 (Dose finding) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with advanced prostate cancer in Part 2 (Dose expansion) of study.
Arms & interventions
- DrugPasritamig
Pasritamig will be administered intravenously.
- DrugJNJ-86974680
JNJ-86974680 will be administered orally.
Outcome measures
Primary
Number of Participants With Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines and ocular events will be graded using the alternative scale provided in the protocol.
Time frame: Up to 1 year 2 months
Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)
High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.
Time frame: Up To Day 22
Secondary
Objective Response Rate (ORR)
Time frame: Up to 1 year 2 months
Prostate-Specific Antigen (PSA) Response Rate
Time frame: Up to 1 year 2 months
Duration of Response (DOR)
Time frame: Up to 1 year 2 months
Radiographic Progression-Free Survival (rPFS)
Time frame: Up to 1 year 2 months
Time to Response (TTR)
Time frame: Up to 1 year 2 months
Serum Concentration of Pasritamig
Time frame: Up to 1 year 2 months
Plasma Concentration of JNJ-86974680
Time frame: Up to 1 year 2 months
Number of Participants With Anti-Pasritamig Antibodies
Time frame: Up to 1 year 2 months
Eligibility criteria
Study locations (3)
Florida Cancer Specialists
Sarasota, Florida, 34232
Columbia University Medical Center
New York, New York, 10032
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106