Neoplasms
Conditions
Interventions
JNJ-63723283
JNJ-63723283 will be administered by IV infusion or SC injection or infusion.
In Part 1, the first cohort will receive JNJ-63723283 at a starting dose of 80 milligram (mg), intravenous (I
Sponsors
Fujikawa Ei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: - Parts 1-4: Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1 - Parts 1-4: Has thyroid function laboratory values within normal range - Parts 1-4: Females of childbearing potential must have a negative serum pregnancy test - Parts 1-4: Willing and able to adhere to the prohibitions and restrictions specified in this protocol - For Part 2 only: Participants enrolled into Part 2 must have tumor tissue available for correlative studies. Fresh tumor biopsy is preferred. Archival tissue must meet the following criteria: archival sections within 4 months of sectioning that have been stored at 2 degree to 8 degree Celsius in the dark or archival tumor blocks within 5 years of collection. Participants without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy - Parts 1 to 4: Have evaluable disease
Exclusion criteria
Exclusion criteria: Exclusion Criteria: - Has uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure (New York Heart Association class III-IV), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that would limited compliance with study requirements - Has had prior treatment with an anti-Programmed-cell death receptor-1 (PD-1) antibody, anti-the ligand to programmed-cell death 1 (PD-L1) antibody or anti-the ligand to programmed-cell death 2 (PD-L2) antibody - Treatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 halflives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administration - Grade 3 or higher toxicity effects from previous treatment with immunotherapy - A female who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 5 months after the last dose of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Frequency and Severity of Dose-Limiting Toxicity (DLT) Up to 2 years 6 months Frequency and severity of dose-limiting toxicity will be reported. Part 2: Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Subjects With Selected Advanced Solid Tumors Up to 2 years 6 months Objective Response Rate (ORR) is defined as percentage of subjects with best objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria. Parts 3 and 4: Area Under the Serum Concentration Versus Time Curve from Time Zero to Dosing Interval (AUC [0-tau]) Up to 2 years 6 months AUC (0-tau) is defined as area under the serum concentration versus time curve from time zero to dosing interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| Parts 1, 2 3, and 4: Number of Participants With Adverse Events (AEs) as a Measure of Safety Up to 2 years 6 months An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Parts 1, 2 and 3, and 4: Maximum Observed Serum Concentration (Cmax) Up to 2 years 6 months The Cmax is the maximum observed serum concentration. Parts 1 and 2: Area Under the Serum Concentration Versus Time Curve Between time t1 and t2 (AUC [t1-t2]) Up to 2 years 6 months AUC (t1-t2) is defined as the area under the serum concentration versus time curve between time t1 and t2. Parts 1, 2 and 3: Elimination Half-Life (t1/2) Up to 2 years 6 months The elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. Parts 1 and 2: Total Systemic Clearance of (CL) Up to 2 years 6 months Total systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Parts 1 and 2: Volume of Distribution at Steady-State (Vss) Up to 2 years 6 months The Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of JNJ-63723283 at steady state. Parts 1 and 2: Accumulation Ratio (R) Up to 2 years 6 months The R is obtained by dividing AUC at two different time points. Parts 3 and 4: Average Concentration (Cavg) of JNJ-63723283 Up to 2 years 6 months Cavg of JNJ-63723283 will be reported. Parts 3 and 4: Area Under the Serum Concentration Versus Time Curve Between Time Zero and Time t (AUC [0-t]) Up to 2 years 6 months AUC (0-t) is defined as area under the serum concentration versus time curve between time zero and time t. Parts 3: Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinity]) Up to 2 | — |
Countries
Argentina, Brazil, Bulgaria, China, Germany, Hungary, India, Italy, Japan, Mexico, Poland, Portugal, Republic of Korea, Republic of Moldova, Russian Federation, Spain, Sweden, Thailand, Turkey, United Kingdom Of Great Britain And Northern Irela, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed