CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 7 enrolled
Drug / intervention
Nemtabrutinibdrug
Likely dose
Nemtabrutinib 45 mg or 65 mg orally once dailyAI-extracted
Key inclusion· 4
  • ✓Histologically confirmed B-cell malignancy (CLL, SLL, Waldenström's macroglobulinemia, lymphoplasmacytic lymphoma, or other B-cell neoplasm)
  • ✓Failed or intolerant to ≥2 prior treatment regimens (given in combination or sequentially) OR received ≥1 prior BTK inhibitor regimen (when BTK inhibitor is approved as first-line therapy)
  • ✓Ability to swallow and retain oral medication
  • ✓Japanese nationality
Key exclusion· 6
  • ✕Active Hepatitis B or C virus infection at study entry
  • ✕History of second malignancy unless curative treatment completed with no evidence of malignancy for 3 years
  • ✕Known history of HIV infection
  • ✕Clinically significant gastrointestinal abnormalities that might alter absorption (gastric bypass, gastrectomy)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05673460
NCT05673460Phase 1Completed
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A Phase 1 Clinical Study of Nemtabrutinib (MK-1026) in Japanese Participants With Hematological Malignancies (BELLWAVE-002)

Merck Sharp & Dohme LLC·interventional·Posted Jan 6, 2023·Updated May 13, 2026

In Brief

A Phase 1 clinical trial evaluating Nemtabrutinib for Mature B-cell Neoplasms. Completed, enrolled 7 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMature B-cell Neoplasms
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJan 6, 2023
Enrollment StartFeb 13, 2023
Primary CompletionApr 28, 2025
Study CompletionSep 3, 2025
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 3.5 years ago

Interventions

Nemtabrutinibdrug

Nemtabrutinib tablets will be administered orally QD at dosage of 45 mg or 65 mg