A Clinical Study of Nemtabrutinib in Japanese Participants With Hematological Malignancies (MK-1026-002)
- Sponsor
- Merck Sharp & Dohme LLC
- Study ID
- NCT05673460
- Phase
- PHASE1
- Status
- Completed
Conditions
- Mature B-cell Neoplasms
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nemtabrutinib — DRUGNemtabrutinib tablets will be administered orally QD at dosage of 45 mg or 65 mg
Study Details
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.
Key Dates
- Start date
- Feb 13, 2023
- Status verified
- May 2026
- Primary completion
- Apr 28, 2025
- Completion
- Sep 3, 2025
Study Design
- Enrollment
- 7 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: NemtabrutinibParticipants receive nemtabrutinib at specified dose orally once daily (QD) until progressive disease (PD) or discontinuation
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 ]