A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumours

Official Title

A Phase 1, First-in-Human, Dose Escalation Study of JNJ-63898081, in Subjects With Advanced Stage Solid Tumours

Summary:

The main purpose of this study are to determine the recommended Phase 2 dose (RP2D) regimen and the maximum tolerated dose, and to determine the safety of JNJ-63898081.

Trial Description

Primary Outcome:

• Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
• Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
• Part 1: Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

• Part 1 and Part 2: Serum Concentrations of JNJ-63898081
• Part 1 and 2: Systemic Cytokine Concentrations
• Part 1 and 2: Concentration of Markers of T-Cell Activation
• Part 1 and 2: Number of Participants with JNJ-63898081 Antibodies
• Serum Prostate Specific Antigen (PSA) Concentration
• Percentage of JNJ-63898081 Receptor Occupancy

View this trial on ClinicalTrials.gov