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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Mature B-cell Neoplasms

Treatments

Drug: Nemtabrutinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05673460

MK-1026-002 (Other Identifier)

1026-002

jRCT2031220583 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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