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NCT05673460
A Clinical Study of Nemtabrutinib in Japanese Participants With Hematological Malignancies (MK-1026-002)
Conditions: Mature B-cell Neoplasms
Sex: All
Ages: 18 Years – N/A
Phase: PHASE1
Enrollment: 12
Sponsor: Merck Sharp & Dohme LLC
Location: Japan
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.
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 neoplasmFailed 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 therapyHave the ability to swallow and retain oral medicationIs JapaneseExclusion Criteria:Active Hepatitis B virus (HBV)/Hepatitis C virus (HCV) infection at study entryHistory of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 yearsKnown history of human immunodeficiency virus (HIV) infectionClinically significant gastrointestinal abnormalities that might alter absorption (eg, gastric bypass surgery, gastrectomy)Underlying history of severe bleeding disordersHistory or concurrent condition of pneumonitis/interstitial lung disease
Source: ClinicalTrials.gov (NCT05673460). StuddyBuddy aggregates publicly available trial information.