Phase
Condition
Cancer
Carcinoma
Treatment
Erdafitinib
JNJ-63723283
Clinical Study ID
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Radiographically, histologically, or cytologically confirmed advanced or refractorysolid tumor(s) that is metastatic or unresectable, and previously received or wasineligible for standard treatment options. Participants with solid tumor(s) forwhich anti-PD-1 or anti-PD-L1 antibody as a monotherapy is approved in Japan areeligible.
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 andpracticing a highly effective, preferably user-independent method of contraception (failure rate of less than (<) 1 percent (%) per year when used consistently andcorrectly) and agrees to remain on a highly effective method while receiving studyintervention and continue for 5 months following discontinuation of JNJ-63723283 or 3 months following discontinuation of erdafitinib, whichever is longer. Especiallyparticipants receiving erdafitinib must agree to use two contraceptive methods andone must be user-independent method; Examples of highly effective contraceptivesinclude: user-independent methods: intrauterine device (IUD) or intrauterinecontraceptive system (IUS) and user-dependent methods: combined (estrogen- andprogestogen-containing) hormonal contraception or progesterone-containing hormonalcontraception. c) Agree not to donate eggs (ova, oocytes), during the study andcontinue for 5 months following discontinuation of JNJ-63723283 or 3 monthsfollowing discontinuation of erdafitinib, whichever is longer
A male participant must wear a condom when engaging in any activity that allows forpassage of ejaculate to another person and must agree not to donate sperm for 5months following discontinuation of JNJ-63723283 or 5 months followingdiscontinuation of erdafitinib, whichever is longer
Exclusion
Exclusion Criteria:
Had prior treatment with an anti-PD-1 antibody, anti-PD-L1 antibody or anti-PDL2antibody within 30 days of first study drug administration and/or has an ongoingGrade 2 or higher immunotherapy-related toxicity. If the subject has an experienceof treatment with these agents, the subject must not have had severeimmunotherapy-related toxicity
History of or concurrent interstitial lung disease
Active autoimmune disease or a documented history of autoimmune disease thatrequires 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 corticosteroidsdoses greater than (>) 10 milligram per day (mg/day) prednisolone or equivalent),within 2 weeks before the planned first dose of study drug
Study Design
Connect with a study center
National Cancer Center Hospital
Chuo Ku, 104 0045
JapanSite Not Available
National Cancer Center Hospital
Chuo-Ku, 104-0045
JapanSite Not Available
National Cancer Center Hospital East
Kashiwa, 277 8577
JapanSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.