A Clinical Study of Nemtabrutinib in Japanese Participants With Hematological Malignancies (MK-1026-002)

• Status: Not yet recruiting
• Trial end date: 2026-03-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of nemtabrutinib in Japanese participants with mature B-cell neoplasms.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme LLC

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