Phase 1
N=7
A Clinical Study of Nemtabrutinib in Japanese Participants With Hematological Malignancies (MK-1026-002)
Mature B-cell Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT05673460 ↗Enrolled (actual)
7
Serious AEs
28.6%
Results posted
May 2026
Primary outcome: Primary: Number of Participants Who Experience Dose Limiting Toxicities (DLTs) Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Nemtabrutinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience Dose Limiting Toxicities (DLTs) Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 |
0; 0 | — |
| PRIMARY Number of Participants Who Experience Adverse Events (AEs) |
3; 4 | — |
| PRIMARY Number of Participants Discontinuing Study Treatment Due to AEs |
0; 0 | — |
| SECONDARY Area Under the Curve From Dosing to 24 Hours Postdose (AUC0-24) of Nemtabrutinib |
8000; 9890 | — |
| SECONDARY Minimum Concentration (Cmin) of Nemtabrutinib |
190; 218 | — |
| SECONDARY Maximum Concentration (Cmax) of Nemtabrutinib |
638; 917 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of Nemtabrutinib |
1.88; 1.43 | — |
| SECONDARY Objective Response Rate (ORR) as Assessed by Investigator |
100.0; 100.0; 0.0; 0.0 | — |
| SECONDARY Duration of Response (DOR) as Assessed by Investigator |
NA; NA | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05673460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.