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

Janssen Pharmaceutical K.K.22 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasm

Interventions

JNJ-63723283DRUG

JNJ-63723283 will be administered intravenously.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: Up to 6 weeks (maximum)

Secondary Outcomes

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

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Severity of Adverse Event will be graded by using NCI-CTCAE, version 4.03. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death) with Grades as follows: Grade 1 (Mild) Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life threatening) and Grade 5 (Death).