Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04876092 | A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL | PHASE1 | COMPLETED | 45 | — | — | Jul 28, 2021 | Feb 13, 2025 | Aug 21, 2025 | 10 | Denmark, France +2 |
| NCT03900598 | A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) | PHASE1 | COMPLETED | 226 | — | — | Apr 3, 2019 | May 22, 2025 | Jun 22, 2025 | 47 | United States, Australia +10 |
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...