Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-67856633 · 2 trials · 2 indications
Percentage of Participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematological toxicity or hematological toxicity.
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
The DLTs are based on drug related adverse events and defined as any of the following events: any toxicity that would require discontinuation of treatment; and/or hematological / non-hematological toxicity of Grade 3 or higher.
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 |
|---|---|---|
| JNJ-67856633 and Ibrutinib | EXPERIMENTAL | Participants will receive JNJ-67856633 together with Ibrutinib orally on a 21-day cycle. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET). |
| Part 1 (Dose Escalation): JNJ-67856633 | EXPERIMENTAL | Participants will receive JNJ-67856633 until disease progression, intolerable toxicity, withdrawal of consent, or the investigator or sponsor decision. Subsequent dose levels will be assigned by the sponsor using an adaptive dose escalation strategy based on all available safety, pharmacokinetic (PK), and biomarker data. |
| Part 2 (Cohort Expansion): JNJ-67856633 | EXPERIMENTAL | Participants will receive JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-67856633 | DRUG | Participants will receive JNJ-67856633 orally. |
| Ibrutinib | DRUG | Participants will receive Ibrutinib orally. |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 * Cardiac parameters within the specified range * Women of childbearing potential must agree to all of the following during the study and for 3 months after the last dose of study drug: a) use a barri...
JNJ-67856633 is an investigational small molecule being studied for the treatment of B-cell chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL). It is in Phase 1 clinical development and is not yet approved by the FDA.
JNJ-67856633 is a MALT1 inhibitor. MALT1 is a protease involved in B-cell receptor signaling, and inhibiting it is thought to disrupt the survival and proliferation of malignant B cells in conditions like chronic lymphocytic leukemia and non-Hodgkin's lymphoma.
JNJ-67856633 is being developed by Johnson & Johnson (NYSE: JNJ). The company has sponsored two Phase 1 clinical trials of the drug in patients with B-cell malignancies.
JNJ-67856633 is in Phase 1 clinical development. Both of its clinical trials have been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities.
JNJ-67856633 has been studied in two completed Phase 1 trials: NCT03900598, a single-agent study in non-Hodgkin's lymphoma and chronic lymphocytic leukemia, and NCT04876092, a combination study with ibrutinib in B-cell NHL and CLL.
Yes, JNJ-67856633 is a MALT1 inhibitor. It is being investigated for its activity against MALT1, a target in B-cell malignancies, in both monotherapy and combination settings.