jRCT2080223997CompletedPhase 1
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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Janssen Pharmaceutical K.K.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of Participants with Dose Limiting Toxicity (DLT)
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
Eligibility Criteria
- Ages
- 20age old over to No limit (—)
- Sex
- All
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 option. 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;
- •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
Outcomes
Primary Outcomes
Number of Participants with Dose Limiting Toxicity (DLT)
Time Frame: Up to 6 weeks (maximum)
Phase 1a and Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT)
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: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Secondary Outcomes
- Number of Participants with Adverse Events and Immune-Related Adverse Event (irAE) by Severity(Approximately up to 3 years)
- Number of Participants With Clinically Significant Changes in Vital Signs as a Measure of Safety and Tolerability(Approximately up to 3 years)
- Number of Participants With Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability(Approximately up to 3 years)
- Number of Participants With ECG Abnormalities as a Measure of Safety and Tolerability(Approximately up to 3 years)
- Maximum Serum Concentration (Cmax) of JNJ-63723283(Approximately up to 3 years)
- Serum Concentration Immediately Prior to the Next Drug Administration (Ctrough) of JNJ-63723283(Approximately up to 3 years)
- Time to reach Maximum Observed serum Concentration (Tmax) of JNJ-63723283(Approximately up to 3 years)
- Area Under the Serum Concentration-Time Curve Between 2 Defined Sampling Points, (t1 and t2) (AUC[t1-t2]) of JNJ-63723283(Approximately up to 3 years)
- Elimination Half-Life (t1/2) of JNJ-63723283(Approximately up to 3 years)
- Total Systemic Clearance (CL) of JNJ-63723283(Approximately up to 3 years)
- Volume of Distribution at Steady-State (Vss) of JNJ-63723283(Approximately up to 3 years)
- Cmax of Erdafitinib(Approximately up to 3 years)
- Ctrough of Erdafitinib(Approximately up to 3 years)
- Numb+H62+H63(Approximately up to 3 years)
Investigators
Study Sites (1)
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