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

NCT03547037 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10847163723283LUC1002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Phase 1a and Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT)

  The DLTs are based on drug-related adverse events and defined as any of the following events: Infusion-related reactions, non-hematologic toxicity of Grade 3 or higher, or certain hematologic toxicity.

  Up to 6 weeks (maximum)

• Phase 1a and Phase 1b: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

  Severity of DLT will be graded by using NCI-CTCAE, version 4.03. Severity scale ranges from Grade 1 to Grade 5 with Grades as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), and Grade 5 (Death).

  Up to 6 weeks (maximum)

Secondary Outcomes (14)

• Phase 1b: Number of Participants with Adverse Events and Immune-Related Adverse Event (irAE) by Severity

  Approximately up to 3 years

• Phase 1a and Phase 1b: Number of Participants With Clinically Significant Changes in Vital Signs as a Measure of Safety and Tolerability

  Approximately up to 3 years

• Phase 1a and Phase 1b: Number of Participants With Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability

  Approximately up to 3 years

• Phase 1a and Phase 1b: Number of Participants With ECG Abnormalities as a Measure of Safety and Tolerability

  Approximately up to 3 years

• Phase 1a and Phase 1b: Maximum Serum Concentration (Cmax) of JNJ-63723283

  Approximately up to 3 years

Study Arms (2)

Phase 1a: JNJ-63723283 (Monotherapy)

EXPERIMENTAL

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

Drug: JNJ-63723283

Phase 1b: Erdafitinib Combination

EXPERIMENTAL

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

Drug: JNJ-63723283; Drug: Erdafitinib

Interventions

JNJ-63723283 DRUG

JNJ-63723283 will be administered intravenously.

Also known as: Cetrelimab

Phase 1a: JNJ-63723283 (Monotherapy); Phase 1b: Erdafitinib Combination

Erdafitinib DRUG

Erdafitinib will be administered orally.

Phase 1b: Erdafitinib Combination

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (2)

National Cancer Center Hospital

Chūōku, 104 0045, Japan

Location

National Cancer Center Hospital East

Kashiwa, 277 8577, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

erdafitinib

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 6, 2018
• Study Start: August 31, 2018
• Primary Completion: July 4, 2022
• Study Completion: July 4, 2022
• Last Updated: April 28, 2025

Record last verified: 2025-04

Locations

JP (2)