NCT03547037

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-Programmed Cell Death (PD)-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Participants With Advanced Solid Cancers

A Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Subjects With Advanced Solid Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to identify the recommended Phase 2 dose (RP2D) of JNJ-63723283 as a monotherapy (Phase 1a part) and to identify the RP2D of JNJ-63723283 when administered in combination with Erdafitinib (Phase 1b part).

Conditions

• Neoplasm

Interventions

Type	Name	Description
DRUG	JNJ-63723283	JNJ-63723283 will be administered intravenously.
DRUG	Erdafitinib	Erdafitinib will be administered orally.

Timeline

• Start date: 2018-08-31
• Primary completion: 2022-07-04
• Completion: 2022-07-04
• First posted: 2018-06-06
• Last updated: 2025-04-28

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study