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| ID | Type | Description | Link |
|---|---|---|---|
| 63723283LUC1002 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a: JNJ-63723283 (Monotherapy) | Experimental | Participants will receive monotherapy of JNJ-63723283 intravenously. The subsequent dose levels of JNJ-63723283 will be escalated using Bayesian logistic regression model (BLRM). |
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| Phase 1b: Erdafitinib Combination | Experimental | Participants will receive erdafitinib in combination with JNJ-63723283 which will be escalated using BLRM. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-63723283 | Drug | JNJ-63723283 will be administered intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a and Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT) | The DLTs are based on drug-related adverse events and defined as any of the following events: Infusion-related reactions, non-hematologic toxicity of Grade 3 or higher, or certain hematologic toxicity. | 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) | Severity of DLT will be graded by using NCI-CTCAE, version 4.03. Severity scale ranges from Grade 1 to Grade 5 with Grades as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), and Grade 5 (Death). | Up to 6 weeks (maximum) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Number of Participants with Adverse Events and Immune-Related Adverse Event (irAE) by Severity | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Severity of Adverse Event will be graded by using NCI-CTCAE, version 4.03. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death) with Grades as follows: Grade 1 (Mild) Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life threatening) and Grade 5 (Death). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center Hospital | Chūōku | 104 0045 | Japan | |||
| National Cancer Center Hospital East |
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| Erdafitinib | Drug | Erdafitinib will be administered orally. |
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| Approximately up to 3 years |
| Phase 1a and Phase 1b: Number of Participants With Clinically Significant Changes in Vital Signs as a Measure of Safety and Tolerability | Number of participants with clinically significant changes in the vital signs including blood pressure, pulse rate, and body temperature will be reported. | Approximately up to 3 years |
| Phase 1a and Phase 1b: Number of Participants With Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability | Number of participants with clinical laboratory abnormalities (clinical laboratory tests include the following: hematology panel, coagulation panel, serum chemistry panel, endocrine panel, serology and pregnancy test [women only]) will be reported. | Approximately up to 3 years |
| Phase 1a and Phase 1b: Number of Participants With ECG Abnormalities as a Measure of Safety and Tolerability | Number of participants with electrocardiogram (ECG) abnormalities will be reported. | Approximately up to 3 years |
| Phase 1a and Phase 1b: Maximum Serum Concentration (Cmax) of JNJ-63723283 | The Cmax is the maximum observed serum concentration. | Approximately up to 3 years |
| Phase 1a and Phase 1b: Serum Concentration Immediately Prior to the Next Drug Administration (Ctrough) of JNJ-63723283 | Ctrough is the serum concentration immediately prior to the next drug administration of any dose other than the first dose in a multiple dosing regimen. | Approximately up to 3 years |
| Phase 1a and Phase 1b: Time to reach Maximum Observed serum Concentration (Tmax) of JNJ-63723283 | The Tmax is defined as actual sampling time to reach maximum observed serum concentration. | Approximately up to 3 years |
| Phase 1a and Phase 1b: Area Under the Serum Concentration-Time Curve Between 2 Defined Sampling Points, (t1 and t2) (AUC[t1-t2]) of JNJ-63723283 | The AUC(t1-t2) is the area under the serum concentration-time curve between 2 defined sampling points, t1 and t2. | Approximately up to 3 years |
| Phase 1a and Phase 1b: Elimination Half-Life (t1/2) of JNJ-63723283 | T1/2 is the time measured for the serum concentration to decrease by 1 half to its original concentration. | Approximately up to 3 years |
| Phase 1a and Phase 1b: Total Systemic Clearance (CL) of JNJ-63723283 | CL is a quantitative measure of the rate at which JNJ-63723283 is removed from the body. | Approximately up to 3 years |
| Phase 1a and Phase 1b: Volume of Distribution at Steady-State (Vss) of JNJ-63723283 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution is the apparent volume of distribution at steady-state. | Approximately up to 3 years |
| Phase 1b: Cmax of Erdafitinib | The Cmax is the maximum observed plasma concentration. | Approximately up to 3 years |
| Phase 1b: Ctrough of Erdafitinib | Ctrough is the plasma concentration immediately prior to the next drug administration of any dose other than the first dose in a multiple dosing regimen. | Approximately up to 3 years |
| Phase 1a and Phase 1b: Number of Participants With Anti-JNJ 63723283 Antibodies | Number of participants with anti-JNJ 63723283 antibodies will be assessed. | Approximately up to 3 years |
| Kashiwa |
| 277 8577 |
| Japan |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000604580 | erdafitinib |
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