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

NCT ID: NCT03547037

Last Updated: 2025-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2022-07-04

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1a: JNJ-63723283 (Monotherapy)

Participants will receive monotherapy of JNJ-63723283 intravenously. The subsequent dose levels of JNJ-63723283 will be escalated using Bayesian logistic regression model (BLRM).

Group Type: EXPERIMENTAL

JNJ-63723283

Intervention Type: DRUG

JNJ-63723283 will be administered intravenously.

Phase 1b: Erdafitinib Combination

Participants will receive erdafitinib in combination with JNJ-63723283 which will be escalated using BLRM.

Group Type: EXPERIMENTAL

JNJ-63723283

Intervention Type: DRUG

JNJ-63723283 will be administered intravenously.

Erdafitinib

Intervention Type: DRUG

Erdafitinib will be administered orally.

Interventions

JNJ-63723283

JNJ-63723283 will be administered intravenously.

Intervention Type: DRUG

Erdafitinib

Erdafitinib will be administered orally.

Intervention Type: DRUG

Other Intervention Names

Cetrelimab

Eligibility Criteria

Inclusion Criteria

• Radiographically, histologically, or cytologically confirmed advanced or refractory solid tumor(s) that is metastatic or unresectable, and previously received or was ineligible for standard treatment options. Participants with solid tumor(s) for which anti-PD-1 or anti-PD-L1 antibody as a monotherapy is approved in Japan are eligible.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Thyroid function laboratory values within normal range
• A woman must be: a) Not of childbearing potential; b) Of childbearing potential and practicing a highly effective, preferably user-independent method of contraception (failure rate of less than (<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and continue for 5 months following discontinuation of JNJ-63723283 or 3 months following discontinuation of erdafitinib, whichever is longer. Especially participants receiving erdafitinib must agree to use two contraceptive methods and one must be user-independent method; Examples of highly effective contraceptives include: user-independent methods: intrauterine device (IUD) or intrauterine contraceptive system (IUS) and user-dependent methods: combined (estrogen- and progestogen-containing) hormonal contraception or progesterone-containing hormonal contraception. c) Agree not to donate eggs (ova, oocytes), during the study and continue for 5 months following discontinuation of JNJ-63723283 or 3 months following discontinuation of erdafitinib, whichever is longer
• A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person and must agree not to donate sperm for 5 months following discontinuation of JNJ-63723283 or 5 months following discontinuation of erdafitinib, whichever is longer

Exclusion Criteria

• Had prior treatment with an anti-PD-1 antibody, anti-PD-L1 antibody or anti-PDL2 antibody within 30 days of first study drug administration and/or has an ongoing Grade 2 or higher immunotherapy-related toxicity. If the subject has an experience of treatment with these agents, the subject must not have had severe immunotherapy-related toxicity
• History of or concurrent interstitial lung disease
• Active autoimmune disease or a documented history of autoimmune disease that requires systemic steroids or immunosuppressive agents
• Grade 3 or higher toxicity effects from previous treatment with immunotherapy
• Has taken immunosuppressive doses of systemic medications, such as corticosteroids doses greater than (>) 10 milligram per day (mg/day) prednisolone or equivalent), within 2 weeks before the planned first dose of study drug

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

National Cancer Center Hospital

Chūōku, , Japan

National Cancer Center Hospital East

Kashiwa, , Japan

Countries

Japan

Other Identifiers

63723283LUC1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR108471

Identifier Type: -

Identifier Source: org_study_id