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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523297-16-00 | Registry Identifier | EUCT number |
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The purpose of this study is to determine the putative recommended Phase 2 doses (RP2Ds) and optimal dose schedule(s) for JNJ-95566692 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) (Part 1: Dose Escalation) and to further characterize the safety and clinical activity of JNJ-95566692 as a single agent (Arm A) and in combination with JNJ-87801493 (Arm B) at the putative RP2D(s) (Part 2: Dose Expansion).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: JNJ-95566692 | Experimental | Participants will receive escalating doses of JNJ-95566692 in Part 1 (Dose escalation) to determine the putative recommended Phase 2 doses (RP2D[s]) and dosing schedule(s). Participants in Part 2 (Dose expansion) will receive JNJ-95566692 at the putative RP2D(s) determined in Part 1 to further characterize safety, PK (pharmacokinetic), pharmacodynamic (PD) and clinical activity. |
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| Arm B: JNJ-95566692 in combination with JNJ-87801493 | Experimental | Participants will receive escalating doses of JNJ-95566692 in combination with JNJ-87801493 in Part 1 (Dose escalation) to determine the putative RP2D[s] and dosing schedule(s). Participants in Part 2 (Dose expansion) will receive JNJ-95566692 in combination with JNJ-87801493 at the putative RP2D(s) determined in Part 1 to further characterize safety, PK, PD and clinical activity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-95566692 | Drug | JNJ-95566692 will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | 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 for AEs will be specified as per: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grades which are Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (potentially life-threatening) and Grade 5 (death related to adverse event). SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important. | Approximately 2 years and 8 months |
| Part 1: Number of Participants with Dose Limiting Toxicity (DLTs) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | Number of participants with DLTs for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported. The DLTs are drug-related toxicities and are defined as any of the following: fatal toxicity, high grade non-hematologic toxicity, or hematologic toxicity. | Approximately 2 years and 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | Serum concentration for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be assessed using a validated assay method. | Approximately 2 years and 8 months |
| Area Under the Curve During a Dosing Interval (AUCtau) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash Medical Centre | Recruiting | Clayton | 3168 | Australia | ||
| Peter MacCallum Cancer Centre |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/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-87801493 | Drug | JNJ-87801493 will be administered subcutaneously. |
|
AUC tau is defined as area under the serum concentration-time curve during a dosing interval (tau). |
| Approximately 2 years and 8 months |
| Maximum Serum Concentration (Cmax) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | Cmax for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported. | Approximately 2 years and 8 months |
| Minimum Serum Concentration (Cmin) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | Cmin for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported. | Approximately 2 years and 8 months |
| Area Under the Curve (AUC[0-t]) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | AUC(0-t) for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported. | Approximately 2 years and 8 months |
| Half-life (t1/2) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | Half-life (t1/2) for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported. | Approximately 2 years and 8 months |
| Time to Reach Cmax (Tmax) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | Tmax is the time to reach maximum observed serum concentration for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B). | Approximately 2 years and 8 months |
| Apparent Total Body Clearance (CL/F) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | CL/F for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported. | Approximately 2 years and 8 months |
| Apparent Volume of Distribution (V/F) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | V/F for JNJ-95566692 (arm A) and in combination with JNJ-87801493 (arm B) will be reported. | Approximately 2 years and 8 months |
| Number of Participants with Anti-JNJ-95566692 Antibodies in Arm A and Arm B | Participants with presence of antibodies binding to JNJ-95566692 in arm A and arm B will be reported. | Approximately 2 years and 8 months |
| Number of Participants with Anti-JNJ-87801493 Antibodies in Arm B | Participants with presence of antibodies binding to JNJ-87801493 in arm B will be reported. | Approximately 2 years and 8 months |
| Part 2: Overall Response for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | Overall response is defined as a best response of partial response (PR) or better as assessed by the investigator according to standard response criteria per Lugano. | Approximately 2 years and 8 months |
| Part 2: Complete Response (CR) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | Complete response (CR) is defined as a best response of CR as assessed by the investigator according to standard response criteria per Lugano. | Approximately 2 years and 8 months |
| Part 2: Time to Response (TTR) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | TTR is defined for participants who achieved a response of PR or better as the time from the first dose of study treatment to the first response of PR or better. | Approximately 2 years and 8 months |
| Part 2: Duration of Response (DOR) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | DOR is defined for participants who achieved a response of PR or better as the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease, initiation of a new systemic anti-cancer therapy or death. | Approximately 2 years and 8 months |
| Part 2: Progression-free survival (PFS) for JNJ-95566692 (Arm A) And in Combination With JNJ-87801493 (Arm B) | PFS is defined as the time from the date of first dose of study treatment to the date of first documented evidence of progressive disease (as defined in the disease-specific response criteria; unless) or death due to any cause, whichever occurs first. | Approximately 2 years and 8 months |
| Recruiting |
| Melbourne |
| 3000 |
| Australia |
| Macquarie University Hospital | Recruiting | North Ryde | 2109 | Australia |
| Scientia Clinical Research | Recruiting | Randwick | 2031 | Australia |
| UZ Antwerpen | Recruiting | Edegem | 2650 | Belgium |
| Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman | Recruiting | Liège | 4000 | Belgium |
| Hopital Claude Huriez | Recruiting | Lille | 59000 | France |
| CHU Pitie Salpetriere | Recruiting | Paris | 75013 | France |
| CHU Lyon Sud | Recruiting | Pierre-Bénite | 69495 | France |
| Institut Universitaire du Cancer Toulouse Oncopole | Recruiting | Toulouse | 31100 | France |
| Hosp Univ Vall D Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hosp. Clinic de Barcelona | Recruiting | Barcelona | 8036 | Spain |
| Hosp Univ Fund Jimenez Diaz | Recruiting | Madrid | 28040 | Spain |
| Hosp. Univ. 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hosp Univ Hm Sanchinarro | Recruiting | Madrid | 28050 | Spain |
| SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi | Recruiting | Ankara | 06200 | Turkey (Türkiye) |
| Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi | Recruiting | Ankara | 06620 | Turkey (Türkiye) |
| Memorial Antalya Hastanesi Faz 1 Klinik Arastirma Merkezi | Recruiting | Antalya | 07025 | Turkey (Türkiye) |
| Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi | Recruiting | Istanbul | 34010 | Turkey (Türkiye) |
| 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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