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Completed

NCT Number: NCT05673460

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

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

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Key information

Conditions

Mature B-cell Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nagoya University Hospital ( Site 0003), Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nemtabrutinib

Drug

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

Other names: MK-1026, ARQ 531

Primary outcomes

  1. Number of Participants Who Experience Dose Limiting Toxicities (DLTs) Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0

    Time frame: Up to approximately 4 weeks

    A DLT is ≥1 of: Grade ≥3 nonhematologic toxicity with exception of Grade 3 nausea, vomiting, diarrhea, rash, fatigue, and uncontrolled hypertension lasting >72 hours despite optimal supportive case; Grade 4 hematologic toxicity lasting >7 days, Grade 4 platelet count decreased of any duration (with exceptions), or Grade 3 platelet count decreased with bleeding (with exceptions), or Grade 3 or higher febrile neutropenia of any duration; Grade 3 or Grade 4 nonhematologic laboratory abnormality, if results in drug induced liver injury (DILI), or medical intervention is required, or the abnormality leads to hospitalization, or the abnormality persists for >1 week (with exceptions); missing >25% of nemtabrutinib doses as a result of drug-related AE(s); Grade 5 toxicity. Toxicities will be graded using NCI-CTCAE version 5.0 except hematologic toxicities in participants with chronic lymphocytic leukemia (CLL) assessed according to the International Workshop on CLL (iwCLL) criteria.

  2. Number of Participants Who Experience Adverse Events (AEs)

    Time frame: Up to approximately 26 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  3. Number of Participants Discontinuing Study Treatment Due to AEs

    Time frame: Up to approximately 26 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Secondary outcomes

  1. Area Under the Curve From Dosing to 24 Hours Postdose (AUC0-24) of Nemtabrutinib

    Time frame: Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose

    AUC0-24 is the area under the curve of plasma concentration of nemtabrutinib from dosing to 24 hours postdose.

  2. Minimum Concentration (Cmin) of Nemtabrutinib

    Time frame: Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose

    Cmin is the lowest observed plasma concentration.

  3. Maximum Concentration (Cmax) of Nemtabrutinib

    Time frame: Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose

    Cmax is the lowest observed plasma concentration.

  4. Time to Maximum Concentration (Tmax) of Nemtabrutinib

    Time frame: Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose

    Tmax is the time to reach Cmax.

  5. Objective Response Rate (ORR) as Assessed by Investigator

    Time frame: Up to approximately 26 months

    ORR is the proportion of participants in the analysis population with objective response. Objective response is defined as participants who achieve at least a partial response (PR) per disease-specific criteria as assessed by investigator. Data are presented separately for participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and non-CLL/SLL participants.

  6. Duration of Response (DOR) as Assessed by Investigator

    Time frame: Up to approximately 26 months

    For participants who demonstrate an objective response as assessed by investigator, per disease-specific criteria, duration of response is defined as the time from the first documented evidence of an objective response until disease progression or death due to any cause, whichever occurs first.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 1 Clinical Study of Nemtabrutinib (MK-1026) in Japanese Participants With Hematological Malignancies (BELLWAVE-002)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2023
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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