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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-13

Study Completion Date

2025-09-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Mature B-cell Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nemtabrutinib

Participants receive nemtabrutinib at specified dose orally once daily (QD) until progressive disease (PD) or discontinuation

Group Type EXPERIMENTAL

Nemtabrutinib

Intervention Type DRUG

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

Interventions

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Nemtabrutinib

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

Intervention Type DRUG

Other Intervention Names

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MK-1026 ARQ 531

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No