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JNJ-64264681 · 2 trials · 3 indications
Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
The DLTs are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher (as specified in protocol).
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
| Arm | Type | Description |
|---|---|---|
| Part A: Dose escalation: JNJ-64264681 and JNJ-67856633 | EXPERIMENTAL | Participants will receive JNJ-64264681 and JNJ-67856633 will be administered together until disease progression, intolerable toxicity, withdrawal of consent, or the investigator. |
| Part B: Cohort Expansion: JNJ-64264681 and JNJ-67856633 | EXPERIMENTAL | Participants will receive JNJ-64264681 and JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1. |
| JNJ-64264681: Dose Escalation and Expansion | EXPERIMENTAL | Participants will receive oral administration of JNJ-64264681 capsule at a dose assigned by the sponsor Study Evaluation Team (SET), based on the available safety, pharmacokinetics, and pharmacodynamics data in dose escalation treatment group (Part 1); and recommended Phase 2 dose (RP2D) determined in Part 1 in cohort expansion treatment group (Part 2). |
| Name | Type | Description |
|---|---|---|
| JNJ-64264681 | DRUG | JNJ-64264681 capsules will be administered orally. |
| JNJ-67856633 | DRUG | JNJ-67856633 capsules or tablets will be administered orally. |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 * Cardiac parameters within the following range: corrected QT interval (QTcF) \<= 480 milliseconds * Participants with B cell non-Hodgkin lymphoma (NHL) must have tumor tissue available at baseline as...
JNJ-64264681 is an investigational small molecule being developed by Johnson & Johnson for the treatment of non-Hodgkin lymphoma and chronic lymphocytic leukemia. It is in Phase 1 clinical development and has been studied in two completed early-stage trials. It is not an approved therapy.
JNJ-64264681 is being studied for use in non-Hodgkin lymphoma, a group of blood cancers affecting lymphocytes. Both of its Phase 1 trials enrolled adults with non-Hodgkin lymphoma and chronic lymphocytic leukemia. The trials are complete, and the drug remains investigational for these cancers.
JNJ-64264681 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored both Phase 1 studies of the compound in non-Hodgkin lymphoma and chronic lymphocytic leukemia.
JNJ-64264681 is in Phase 1 clinical development. Two Phase 1 trials have been conducted, and both are listed as completed, with no active trials currently recruiting. The drug is investigational and has not been approved for any indication.
JNJ-64264681 has been evaluated in two completed Phase 1 trials. NCT04210219 studied the drug in non-Hodgkin lymphoma and chronic lymphocytic leukemia with 85 participants. NCT04657224 studied JNJ-64264681 with JNJ-67856633 in non-Hodgkin lymphoma and chronic lymphocytic leukemia with 75 participants.
The two completed Phase 1 trials of JNJ-64264681 enrolled a combined total of 160 adult participants. NCT04210219 enrolled 85 participants, and NCT04657224 enrolled 75 participants. Both studies included patients with non-Hodgkin lymphoma and chronic lymphocytic leukemia and were conducted across multiple countries.