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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2022
• Main ID: NCT03547037
• Date of registration: 24/05/2018
• Prospective Registration: Yes
• Primary sponsor: Janssen Pharmaceutical K.K.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: August 31, 2018
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03547037
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Japan

Contacts

• Name: Janssen Pharmaceutical K.K., Japan Clinical Trial
• Affiliation: Janssen Pharmaceutical K.K.

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Neoplasm

Intervention(s)

Drug: JNJ-63723283

Drug: Erdafitinib

Primary Outcome(s)

Phase 1a and Phase 1b: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) [Time Frame: Up to 6 weeks (maximum)]

Phase 1a and Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT) [Time Frame: Up to 6 weeks (maximum)]

Secondary Outcome(s)

Phase 1a and Phase 1b: Maximum Serum Concentration (Cmax) of JNJ-63723283 [Time Frame: Approximately up to 3 years]

Phase 1b: Cmax of Erdafitinib [Time Frame: Approximately up to 3 years]

Phase 1a and Phase 1b: Volume of Distribution at Steady-State (Vss) of JNJ-63723283 [Time Frame: Approximately up to 3 years]

Phase 1a and Phase 1b: Total Systemic Clearance (CL) of JNJ-63723283 [Time Frame: Approximately up to 3 years]

Phase 1a and Phase 1b: Area Under the Serum Concentration-Time Curve Between 2 Defined Sampling Points, (t1 and t2) (AUC[t1-t2]) of JNJ-63723283 [Time Frame: Approximately up to 3 years]

Phase 1a and Phase 1b: Serum Concentration Immediately Prior to the Next Drug Administration (Ctrough) of JNJ-63723283 [Time Frame: Approximately up to 3 years]

Phase 1a and Phase 1b: Elimination Half-Life (t1/2) of JNJ-63723283 [Time Frame: Approximately up to 3 years]

Phase 1b: Number of Participants with Adverse Events and Immune-Related Adverse Event (irAE) by Severity [Time Frame: Approximately up to 3 years]

Phase 1a and Phase 1b: Number of Participants With Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability [Time Frame: Approximately up to 3 years]

Phase 1a and Phase 1b: Number of Participants With Anti-JNJ 63723283 Antibodies [Time Frame: Approximately up to 3 years]

Phase 1b: Ctrough of Erdafitinib [Time Frame: Approximately up to 3 years]

Phase 1a and Phase 1b: Time to reach Maximum Observed serum Concentration (Tmax) of JNJ-63723283 [Time Frame: 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 [Time Frame: Approximately up to 3 years]

Phase 1a and Phase 1b: Number of Participants With ECG Abnormalities as a Measure of Safety and Tolerability [Time Frame: Approximately up to 3 years]

Secondary ID(s)

CR108471

63723283LUC1002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors