Mature B-cell NeoplasmsPhase 1NCT05673460
A Clinical Study of Nemtabrutinib in Japanese Participants With Hematological Malignancies (MK-1026-002)
A Phase 1 study testing Nemtabrutinib in people with Mature B-cell Neoplasms, run by Merck Sharp & Dohme LLC at 7 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mature B-cell Neoplasms
- What is being tested?
- Nemtabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesJapan
- Study dates
- 13 Feb 2023to 3 Sep 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed B-cell malignancy:
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Waldenström's macroglobulinemia (WM)
- Lymphoplasmacytic lymphoma (LPL)
- Other B-cell neoplasm
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Chiba Cancer Center ( Site 0005)
Chiba, 260-8717
Kyushu University Hospital ( Site 0008)
Fukuoka, 812-8582
National Cancer Center Hospital East ( Site 0002)
Kashiwa, Chiba, 2778577
Nagoya University Hospital ( Site 0003)
Nagoya, Aichi-ken, 466-8560
Okayama University Hospital ( Site 0007)
Okayama, 700-8558
Kindai University Hospital ( Site 0006)
Sayama, Osaka, 589-8511
Yamagata University Hospital ( Site 0001)
Yamagata, 990-9585
About this study
Official title: A Phase 1 Clinical Study of Nemtabrutinib (MK-1026) in Japanese Participants With Hematological Malignancies (BELLWAVE-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.
- Conditions
- Mature B-cell Neoplasms
- Being tested
- Nemtabrutinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NemtabrutinibDrug
Also called MK-1026, ARQ 531
Nemtabrutinib tablets will be administered orally QD at dosage of 45 mg or 65 mg
| Study group | Role | What they receive |
|---|---|---|
| Nemtabrutinib | Experimental | Participants receive nemtabrutinib at specified dose orally once daily (QD) until progressive disease (PD) or discontinuation Receives: Drug: Nemtabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience Dose Limiting Toxicities (DLTs) Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
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.
Measured: Up to approximately 4 weeks
Number of Participants Who Experience Adverse Events (AEs)
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.
Measured: Up to approximately 26 months
Number of Participants Discontinuing Study Treatment Due to AEs
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.
Measured: Up to approximately 26 months
Secondary outcomes (6)
Area Under the Curve From Dosing to 24 Hours Postdose (AUC0-24) of Nemtabrutinib
AUC0-24 is the area under the curve of plasma concentration of nemtabrutinib from dosing to 24 hours postdose.
Measured: Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Minimum Concentration (Cmin) of Nemtabrutinib
Cmin is the lowest observed plasma concentration.
Measured: Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Maximum Concentration (Cmax) of Nemtabrutinib
Cmax is the lowest observed plasma concentration.
Measured: Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Time to Maximum Concentration (Tmax) of Nemtabrutinib
Tmax is the time to reach Cmax.
Measured: Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Objective Response Rate (ORR) as Assessed by Investigator
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.
Measured: Up to approximately 26 months
Duration of Response (DOR) as Assessed by Investigator
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.
Measured: Up to approximately 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start13 Feb 2023
- Primary completion28 Apr 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mature B-cell NeoplasmsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673460
- Sponsor's protocol ID
- 1026-002
- Other IDs
- MK-1026-002, jRCT2031220583
- Status last verified
- May 2026
- First submitted
- 4 Jan 2023
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study of Nemtabrutinib (MK-1026) in Japanese Participants With Hematological Malignancies (BELLWAVE-002)
- ClinicalTrials.gov ID
- NCT05673460
- Acronym / sponsor ID
- 1026-002
- Conditions
- Mature B-cell Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 6 Jan 2023 (actual)
- Results
- Posted 13 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nemtabrutinib | Experimental | Drug: NemtabrutinibParticipants receive nemtabrutinib at specified dose orally once daily (QD) until progressive disease (PD) or discontinuation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed B-cell malignancy:
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NemtabrutinibAlso: MK-1026, ARQ 531Nemtabrutinib tablets will be administered orally QD at dosage of 45 mg or 65 mg | Drug | Nemtabrutinib |
Primary outcome
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.
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.
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.
6 secondary outcomes
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
Minimum Concentration (Cmin) of Nemtabrutinib
Time frame: Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Maximum Concentration (Cmax) of Nemtabrutinib
Time frame: Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose
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
Objective Response Rate (ORR) as Assessed by Investigator
Time frame: Up to approximately 26 months
Duration of Response (DOR) as Assessed by Investigator
Time frame: Up to approximately 26 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nemtabrutinib in people with Mature B-cell Neoplasms, run by Merck Sharp & Dohme LLC at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.