Clinical trial NCT05673460: A Clinical Study of Nemtabrutinib in Japanese Participants With Hematological Malignancies (MK-1026-002)
Official title: A Phase 1 Clinical Study of Nemtabrutinib (MK-1026) in Japanese Participants With Hematological Malignancies (BELLWAVE-002)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Mature B-cell Neoplasms
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-01-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
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
timeFrame: Up to approximately 4 weeks
measure: Number of Participants who Experience Adverse Events (AEs)
timeFrame: Up to approximately 38 months
measure: Number of Participants Discontinuing Study Treatment due to AEs
timeFrame: Up to approximately 38 months
Secondary outcomes:
measure: Area under the Curve (AUC) of Nemtabrutinib
timeFrame: Day 1 of Cycles 1 and 2: Pre-dose,1, 2, 4, 6, 8, 10, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 and 4 hours post-dose (up to ~57 days). Each cycle is 28 days
measure: Maximum Concentration (Cmax) of Nemtabrutinib
timeFrame: Day 1 of Cycles 1 and 2: Pre-dose,1, 2, 4, 6, 8, 10, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 and 4 hours post-dose (up to ~57 days). Each cycle is 28 days
measure: Time to Maximum Concentration (Tmax) of Nemtabrutinib
timeFrame: Day 1 of Cycles 1 and 2: Pre-dose,1, 2, 4, 6, 8, 10, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 and 4 hours post-dose (up to ~57 days). Each cycle is 28 days
measure: Minimum Concentration (Cmin) of Nemtabrutinib
timeFrame: Day 1 of Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 and 4 hours post-dose (up to ~57 days). Each cycle is 28 days
measure: Objective Response Rate (ORR) as Assessed by Investigator
timeFrame: Up to approximately 38 months
measure: Duration of Response (DOR) as Assessed by Investigator
timeFrame: Up to approximately 38 months
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University Hospital ( Site 0003)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0002)
state: Chiba
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 0006)
state: Osaka
city: Chiba
country: Japan
facility: Chiba Cancer Center ( Site 0005)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 0008)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 0007)
city: Yamagata
country: Japan
facility: Yamagata University Hospital ( Site 0001)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: