NCT04397276

A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors

A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) and maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of JNJ-70218902 RP2D(s) in Part 2.

Detailed description

JNJ-70218902, the investigational drug, has been shown in pre-clinical studies to work by attaching to cancer cells and activating immune cells to kill these cancer cells. This study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2) and will enroll adult men with Metastatic Castration-Resistant Prostate Cancer (MCRPC). Study evaluations will include preliminary clinical efficacy, safety, pharmacokinetics, biomarkers and immunogenicity evaluations. This study is divided into 3 periods: screening, treatment and post-treatment. The total duration of the study will be 2.5 years approximately.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	JNJ-70218902	JNJ-70218902 will be administered.

Timeline

• Start date: 2020-07-10
• Primary completion: 2025-09-16
• Completion: 2025-09-16
• First posted: 2020-05-21
• Last updated: 2026-02-17

Locations

7 sites across 3 countries: Canada, Israel, Spain

Regulatory

• FDA-regulated drug study