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

Conditions: Neoplasm

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).


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