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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1026-002 | Other Identifier | MSD | |
| jRCT2031220583 | Registry Identifier | jRCT |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nemtabrutinib | Experimental | Participants receive nemtabrutinib at specified dose orally once daily (QD) until progressive disease (PD) or discontinuation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemtabrutinib | Drug | Nemtabrutinib tablets will be administered orally QD at dosage of 45 mg or 65 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Up to approximately 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose |
| Minimum Concentration (Cmin) of Nemtabrutinib |
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The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Hospital ( Site 0003) | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| National Cancer Center Hospital East ( Site 0002) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nemtabrutinib 45 mg | Participants received nemtabrutinib 45 mg once daily (QD) until progressive disease (PD) or discontinuation. |
| FG001 | Nemtabrutinib 65 mg QD | Participants received nemtabrutinib 60 mg QD until PD or discontinuation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nemtabrutinib 45 mg | Participants received nemtabrutinib 45 mg QD until PD or discontinuation. |
| BG001 | Nemtabrutininb 65 mg | Participants received nemtabrutinib 65 mg QD until PD or discontinuation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Treated participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model, are included. | Posted | Least Squares Mean | 95% Confidence Interval | hr*ng/mL | Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose |
|
Up to ~26 months
All treated participants are included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nemtabrutinib 45 mg | Participants received nemtabrutinib 45 mg QD until PD or discontinuation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myelosuppression | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2025 | Apr 8, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000721068 | ARQ531 |
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Cmin is the lowest observed plasma concentration. |
| 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. | 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. | 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. | 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. | Up to approximately 26 months |
| Kashiwa |
| Chiba |
| 2778577 |
| Japan |
| Kindai University Hospital ( Site 0006) | Sayama | Osaka | 589-8511 | Japan |
| Chiba Cancer Center ( Site 0005) | Chiba | 260-8717 | Japan |
| Kyushu University Hospital ( Site 0008) | Fukuoka | 812-8582 | Japan |
| Okayama University Hospital ( Site 0007) | Okayama | 700-8558 | Japan |
| Yamagata University Hospital ( Site 0001) | Yamagata | 990-9585 | Japan |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received nemtabrutinib 65 mg QD until PD or discontinuation.
|
|
| Secondary | Minimum Concentration (Cmin) of Nemtabrutinib | Cmin is the lowest observed plasma concentration. | Treated participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model, are included. | Posted | Least Squares Mean | 95% Confidence Interval | ng/mL | Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose |
|
|
|
| Secondary | Maximum Concentration (Cmax) of Nemtabrutinib | Cmax is the lowest observed plasma concentration. | Treated participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model, are included. | Posted | Least Squares Mean | 95% Confidence Interval | ng/mL | Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose |
|
|
|
| Secondary | Time to Maximum Concentration (Tmax) of Nemtabrutinib | Tmax is the time to reach Cmax. | Treated participants who complied with the protocol sufficiently to ensure that the data they generated will be likely to exhibit the effects of treatment, according to the underlying scientific model, are included. | Posted | Median | Full Range | Hours | Day 1: Pre-dose and 1, 2, 4, 6, 8, 10, and 24 hours post-dose |
|
|
|
| Secondary | 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. | All treated participants are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 26 months |
|
|
|
| Primary | 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. | All allocated participants, except those who meet any of the following criteria: allocated but not treated; discontinued from the study prior to completing all Cycle 1 safety evaluations for reasons other than treatment-related adverse events (e.g., disease progression) without experiencing a DLT; or received less than 75% of the total planned nemtabrutinib administration in Cycle 1 without experiencing a DLT. | Posted | Number | Participants | Up to approximately 4 weeks |
|
|
|
| Primary | 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. | All treated participants are included. | Posted | Number | Participants | Up to approximately 26 months |
|
|
|
| Primary | 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. | All treated participants are included. | Posted | Number | Participants | Up to approximately 26 months |
|
|
|
| Secondary | 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. | All treated CLL/SLL participants are included. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 26 months |
|
|
|
| 3 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | Nemtabrutinib 65 mg | Participants received nemtabrutinib 65 mg QD until PD or discontinuation. | 3 | 4 | 1 | 4 | 4 | 4 |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
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| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Thirst | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Lymphocyte count increased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Pancreatic enzymes increased | Investigations | MedDRA 28.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
| non-CLL/SLL |
|
|