Clinical trial · Interventional
A Clinical Study of Nemtabrutinib in Japanese Participants With Hematological Malignancies (MK-1026-002)
A Phase 1 Clinical Study of Nemtabrutinib (MK-1026) in Japanese Participants With Hematological Malignancies (BELLWAVE-002)
NCT05673460CI-TRIAL-00111364completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of nemtabrutinib in Japanese participants with mature B-cell neoplasms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mature B-cell Neoplasms | Mature B-Cell Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nemtabrutinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nemtabrutinib
- description
- Participants receive nemtabrutinib at specified dose orally once daily (QD) until progressive disease (PD) or discontinuation
- interventionNames
- Drug: Nemtabrutinib
Primary outcomes (3)
- measure
- Number of Participants Who Experience Dose Limiting Toxicities (DLTs) Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
- timeFrame
- Up to approximately 4 weeks
- description
- A DLT is ≥1 of: Grade ≥3 nonhematologic toxicity with exception of Grade 3 nausea, vomiting, diarrhea, rash, fatigue, and uncontrolled hypertension lasting \>72 hours despite optimal supportive case; Grade 4 hematologic toxicity lasting \>7 days, Grade 4 platelet count decreased of any duration (with exceptions), or Grade 3 platelet count decreased with bleeding (with exceptions), or Grade 3 or higher febrile neutropenia of any duration; Grade 3 or Grade 4 nonhematologic laboratory abnormality, if results in drug induced liver injury (DILI), or medical intervention is required, or the abnormality leads to hospitalization, or the abnormality persists for \>1 week (with exceptions); missing \>25% of nemtabrutinib doses as a result of drug-related AE(s); Grade 5 toxicity. Toxicities will be graded using NCI-CTCAE version 5.0 except hematologic toxicities in participants with chronic lymphocytic leukemia (CLL) assessed according to the International Workshop on CLL (iwCLL) criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Histologically confirmed B-cell malignancy: * Chronic lymphocytic leukemia (CLL) * Small lymphocytic lymphoma (SLL) * Waldenström's macroglobulinemia (WM) * Lymphoplasmacytic lymphoma (LPL) * Other B-cell neoplasm * Failed or intolerant to either at least 2 prior regimens given in combination or sequentially OR have received 1 prior Bruton's tyrosine kinase (BTK)-containing regimen when a BTK inhibitor is approved as first line therapy * Have the ability to swallow and retain oral medication * Is Japanese Exclusion Criteria: * Active Hepatitis B virus (HBV)/Hepatitis C virus (HCV) infection at study entry * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years * Known history of human immunodeficiency virus (HIV) infection * Clinically significant gastrointestinal abnormalities that might alter absorption (eg, gastric bypass surgery, gastrectomy) * Underlying history of severe bleeding disorders * History or concurrent condition of pneumonitis/interstitial lung disease
References
Publications (0)
Data not yet available
No reference posted for this study.