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)

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.

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