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
Status and phase
Completed
Phase 1
Conditions
Neoplasm
Treatments
Drug: JNJ-63723283
Drug: Erdafitinib
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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).
Enrollment
22 patients
Sex
All
Ages
20+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
22 participants in 2 patient groups
Phase 1a: JNJ-63723283 (Monotherapy)
Experimental group
Description:
Participants will receive monotherapy of JNJ-63723283 intravenously. The subsequent dose levels of JNJ-63723283 will be escalated using Bayesian logistic regression model (BLRM).
Treatment:
Drug: JNJ-63723283
Phase 1b: Erdafitinib Combination
Experimental group
Description:
Participants will receive erdafitinib in combination with JNJ-63723283 which will be escalated using BLRM.
Treatment:
Drug: Erdafitinib
Drug: JNJ-63723283
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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