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| ID | Type | Description | Link |
|---|---|---|---|
| 80948543LYM1002 | Other Identifier | Janssen Research & Development, LLC | |
| 2024-514176-41-00 | Registry Identifier | EUCT number |
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The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: Dose Expansion).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-80948543 | Experimental | Participants will receive JNJ-80948543 in combination with JNJ-75348780 to determine the recommended phase 2 regimen (RP2R) in Part 1 (Dose escalation). JNJ-80948543 will be dosed in an escalation manner in combination with fixed doses of JNJ-75348780. In Part 2 (Dose expansion) participants will receive RP2R of JNJ-80948543 as determined in Part 1 in combination with JNJ-75348780. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-80948543 | Drug | JNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose-limiting Toxicity (DLT) | Number of participants with DLT will be reported. DLTs are defined as any of the treatment-related toxicities: any toxicity that would require discontinuation of treatment; Fatal toxicity; Non-hematologic toxicity (Grade 3 toxicity or higher with exceptions); and Hematologic Toxicity (Grade 4 neutrophil count decrease; Grade 4 febrile neutropenia; Grade 3 febrile neutropenia that does not recover with best supportive care within 7 days; Grade 4 platelet count decrease for >=7 days or Grade >3 with Grade >=2 bleeding; Grade 4 anemia). | Up to 1 year and 10 months |
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. | Up to 1 year and 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of JNJ-80948543 and JNJ-75348780 | Serum Concentration for JNJ-80948543 and JNJ-75348780 will be reported. | Up to 1 year and 10 months |
| Area Under the Curve (AUCtau) for JNJ-80948543 and JNJ-75348780 |
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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 |
|---|---|---|---|---|---|---|
| Concord Hospital | Concord | 2139 | Australia | |||
| St Vincents Hospital Melbourne |
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-75348780 | Drug | JNJ-75348780 will be administered as SC injection. |
|
AUC tau is defined as area under the serum concentration-time curve during a dosing interval for JNJ-80948543 and JNJ-75348780.
| Up to 1 year and 10 months |
| Maximum Serum Concentration (Cmax) for JNJ-80948543 and JNJ-75348780 | Cmax for JNJ-80948543 and JNJ-75348780 will be reported. | Up to 1 year and 10 months |
| Time to Reach Cmax (Tmax) for JNJ-80948543 and JNJ-75348780 | Tmax is the time to reach maximum observed serum concentration for JNJ-80948543 and JNJ-75348780. | Up to 1 year and 10 months |
| Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543 and JNJ-75348780 | Number of participants with presence of anti-drug antibodies of JNJ-80948543 and JNJ-75348780 will be assessed. | Up to 1 year and 10 months |
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who have a best response of partial response (PR) or better as assessed by the investigator based on standard response criteria. | Up to 1 year and 10 months |
| Complete Response Rate (CRR) | CR is defined as the percentage of participants who achieve a best response of CR as assessed by the investigator based on standard response criteria. | Up to 1 year and 10 months |
| Duration of Response (DoR) | DOR is defined as the time from the first efficacy evaluation at which the participant meet all criteria for a response of PR or better to the date of first documented evidence of progressive disease or death as assessed by the investigator based on standard response criteria. | Up to 1 year and 10 months |
| Fitzroy |
| 3065 |
| Australia |
| Macquarie University Hospital | North Ryde | 2109 | Australia |
| Hosp Univ Vall D Hebron | Barcelona | 08035 | Spain |
| Hosp. Clinic de Barcelona | Barcelona | 08036 | Spain |
| Inst. Cat. Doncologia-H Duran I Reynals | L'Hospitalet de Llobregat | 08908 | Spain |
| Hosp. Gral. Univ. Gregorio Maranon | Madrid | 28007 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| University Hospitals Of Leicester Nhs Trust | Leicester | Le1 5ww | United Kingdom |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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