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JNJ-95566692 · 1 trial · 1 indication
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.
Number of participants with DLTs for JNJ-95566692 (arm A), in combination with JNJ-87801493 (arm B) and in arms C to G 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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Arm C: JNJ-95566692 and loncastuximab tesirine with or without JNJ-87801493 | EXPERIMENTAL | Participants will receive escalating doses for JNJ-95566692 and loncastuximab tesirine with or without JNJ-87801493 followed by the target dose 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 and loncastuximab tesirine with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1. |
| Arm D: JNJ-95566692 and R-GemOx with or without JNJ-87801493 | EXPERIMENTAL | Participants will receive escalating doses of JNJ-95566692 and R-GemOx (rituximab, gemcitabine, oxaliplatin) with or without JNJ-87801493 followed by the target dose 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 and R-GemOx with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1. |
| Arm E: JNJ-95566692 and lenalidomide with or without JNJ-87801493 | EXPERIMENTAL | Participants will receive escalating doses of JNJ-95566692 and lenalidomide with or without 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 and lenalidomide with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1. |
| Arm F: JNJ-95566692 and R-CHOP with or without JNJ-87801493 | EXPERIMENTAL | Participants will receive escalating doses of JNJ-95566692 and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) with or without JNJ-87801493 followed by the target dose 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 and R-CHOP with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1. |
| Arm G: JNJ-95566692 and Pola-R-CHP with or without JNJ-87801493 | EXPERIMENTAL | Participants will receive escalating doses of JNJ-95566692 and Pola-R-CHP (polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone) with or without JNJ-87801493 followed by the target dose 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 and Pola-R-CHP with or without JNJ-87801493 at the putative RP2D(s) determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-95566692 | DRUG | JNJ-95566692 will be administered subcutaneously. |
| JNJ-87801493 | DRUG | JNJ-87801493 will be administered subcutaneously. |
| loncastuximab tesirine | DRUG | Loncastuximab tesirine will be administered intervenously. |
| Lenalidomide | DRUG | Lenalidomide will be administered orally. |
| Rituximab | DRUG | Rituximab will be administered intravenously and may be administered subcutaneously after the first administration. |
| Gemcitabine | DRUG | Gemcitabine will be administered intravenously. |
| Oxaliplatin | DRUG | Oxaliplatin will be administered intravenously. |
| Cyclophosphamide | DRUG | Cyclophosphamide will be administered intravenously. |
| Doxorubicin | DRUG | Doxorubicin will be administered intravenously. |
| Vincristine | DRUG | Vincristine will be administered intravenously. |
| Prednisone | DRUG | Prednisone will be administered orally. |
| Polatuzumab vedotin | DRUG | Polatuzumab vedotin will be administered intravenously. |
Inclusion Criteria: * B-cell non-Hodgkin lymphoid malignancies (NHL) according to World Health Organization (WHO) 2022 and no other approved therapies available that would be more appropriate in the investigator's judgment. -Histologic documentation of the following large B-cell lymphomas: -diffuse...
JNJ-95566692 is an investigational small molecule being studied for the treatment of non-Hodgkin lymphoma. It is not yet approved for any indication and remains in clinical development. The Phase 1 study enrolls adults with non-Hodgkin lymphoid malignancies, and the trial is biomarker-selected, meaning participants are chosen based on specific molecular characteristics.
JNJ-95566692 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company is the sponsor of the clinical program evaluating the compound in non-Hodgkin lymphoid malignancies.
JNJ-95566692 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The single ongoing trial is a Phase 1 study in participants with non-Hodgkin lymphoid malignancies.
JNJ-95566692 is being evaluated in one clinical trial, NCT07308132, titled A Study of JNJ-95566692 in Participants With Non-Hodgkin Lymphoid Malignancies. The Phase 1 trial is currently recruiting and plans to enroll 340 participants across Australia, Belgium, France, Spain, and Turkey. It is a controlled study open to adults aged 18 and older.
No, JNJ-95566692 is not FDA approved. It is an investigational small molecule in Phase 1 clinical development for non-Hodgkin lymphoma. The only registered study, NCT07308132, is currently recruiting participants and has not been completed.