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

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

NCT ID: NCT05673460

Condition: Mature B-cell Neoplasms

Conditions: Official terms:
Hematologic Neoplasms
Lymphoma, B-Cell

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Nemtabrutinib
Description: Nemtabrutinib tablets will be administered orally QD at dosage of 45 mg or 65 mg
Arm group label: Nemtabrutinib

Other name: MK-1026

Other name: ARQ 531

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.

Criteria for 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 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Nagoya University Hospital ( Site 0003)

Address:
City: Nagoya
Zip: 466-8560
Country: Japan

Facility:
Name: National Cancer Center Hospital East ( Site 0002)

Address:
City: Kashiwa
Zip: 2778577
Country: Japan

Facility:
Name: Kindai University Hospital ( Site 0006)

Address:
City: Osakasayama
Zip: 589-8511
Country: Japan

Facility:
Name: Chiba Cancer Center ( Site 0005)

Address:
City: Chiba
Zip: 260-8717
Country: Japan

Facility:
Name: Kyushu University Hospital ( Site 0008)

Address:
City: Fukuoka
Zip: 812-8582
Country: Japan

Facility:
Name: Okayama University Hospital ( Site 0007)

Address:
City: Okayama
Zip: 700-8558
Country: Japan

Facility:
Name: Yamagata University Hospital ( Site 0001)

Address:
City: Yamagata
Zip: 990-9585
Country: Japan

Start date: February 13, 2023

Completion date: March 30, 2026

Lead sponsor:
Agency: Merck Sharp & Dohme LLC
Agency class: Industry

Source: Merck Sharp & Dohme LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05673460
https://www.merckclinicaltrials.com/