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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) 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.
| 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. |
| Name | Type | Description |
|---|---|---|
| JNJ-95566692 | DRUG | JNJ-95566692 will be administered subcutaneously. |
| JNJ-87801493 | DRUG | JNJ-87801493 will be administered subcutaneously. |
Inclusion Criteria: * B-cell non-Hodgkin lymphoid malignancies (NHL) according to World Health Organization (WHO) 2022 with relapsed or refractory disease and no other approved therapies available that would be more appropriate in the investigator's judgment. • Histologic documentation of the follo...
JNJ-95566692 is an investigational small molecule being developed for the treatment of non-Hodgkin lymphoma. It is currently being studied in a Phase 1 clinical trial in participants with non-Hodgkin lymphoid malignancies. The drug is not yet approved and remains in clinical development.
JNJ-95566692 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 1 clinical development for the treatment of non-Hodgkin lymphoma.
JNJ-95566692 is in Phase 1 clinical development. It is being evaluated in an ongoing, recruiting Phase 1 study in participants with non-Hodgkin lymphoid malignancies. The drug is investigational and has not been approved by regulatory authorities.
JNJ-95566692 is being studied in a single Phase 1 clinical trial with the identifier NCT07308132. This trial is titled 'A Study of JNJ-95566692 in Participants With Non-Hodgkin Lymphoid Malignancies' and is currently recruiting participants in Australia, Belgium, France, Spain, and Turkey.
No alternative names for JNJ-95566692 have been disclosed. The drug is identified solely by its code name JNJ-95566692 in the clinical trial registry and development program.