Overview
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 Advance
Status:
Recruiting
Recruiting
Trial end date:
2022-08-31
2022-08-31
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Janssen Pharmaceutical K.K.Treatments:
Antibodies
Antibodies, Monoclonal
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