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| ID | Type | Description | Link |
|---|---|---|---|
| 79032421STM1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-504896-26-00 | Registry Identifier | EUCT number |
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The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-79032421 and to determine the safety and tolerability of JNJ-79032421 at the RP2D(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Dose Escalation): JNJ-79032421 | Experimental | In Part 1 (Dose escalation), participants will receive JNJ-79032421. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. |
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| Part 2 (Dose Expansion): JNJ-79032421 | Experimental | In Part 2 (Dose expansion), participants will receive JNJ-79032421 at the RP2D regimen(s) determined in Part 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-79032421 | Drug | JNJ-79032421 will be administered. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) | The DLTs are adverse events including certain high grade non-hematologic or hematologic toxicities, or toxicities meeting other specific criteria. | Up to first 21 days after first dose |
| Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity | An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events (ICANS), which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2: Serum Concentration of JNJ-79032421 | Serum concentration of JNJ-79032421 will be reported. | Up to 3 years |
| Part 1 and Part 2: Maximum Observed Analyte Concentration (Cmax) of JNJ-79032421 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hosp Univ Vall D Hebron | Barcelona | 08035 | Spain | |||
| Hosp Univ Fund Jimenez Diaz |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| JNJ-79032421 |
| Drug |
JNJ-79032421 will be administered at RP2D regimen. |
|
Cmax is defined as maximum observed analyte concentration of JNJ-79032421.
| Up to 3 years |
| Part 1 and Part 2: Time to Reach Maximum Observed Analyte Concentration (Tmax) of JNJ-79032421 | Tmax is defined as the time to reach maximum observed analyte concentration of JNJ-79032421. | Up to 3 years |
| Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-79032421 | AUC(t1-t2) is defined as area under the analyte concentration for a specific time interval defined by t1 and t2 (AUC[t1-t2]) of JNJ-79032421. | Up to 3 years |
| Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-79032421 Antibodies | The maximum titers of antibodies to JNJ-79032421 will be summarized for participants positive with antibodies to JNJ-79032421. | Up to 3 years |
| Part 1 and Part 2: Objective Response Rate (ORR) | ORR is defined as the percentage of participants with a best response of complete response or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1), and revised mRECIST for assessment of malignant pleural mesothelioma. | Up to 3 years |
| Part 1 and Part 2: Duration of Response (DOR) | DOR is defined as the duration from the date of initial documentation of a response (PR or CR) to the date of first documented evidence of relapse or death according to RECIST v. 1.1, and revised mRECIST for malignant pleural mesothelioma. | Up to 3 years |
| Part 1 and Part 2: Cancer Antigen (CA) 125 Response Rate for Ovarian Cancer Only | CA 125 response rate is defined as the proportion of participants with ovarian cancer who achieved a partial response or complete response according to the Gynecologic Cancer Intergroup (GCIG) response criteria for CA 125. A CA 125 response is defined as at least 50 percentage (%) reduction in CA 125 levels from a pretreatment sample which must be confirmed and maintained for at least 28 days. | Up to 3 years |
| Madrid |
| 28040 |
| Spain |
| Hosp Univ Hm Sanchinarro | Madrid | 28050 | Spain |