Clinical trial · Interventional
A Study of Nemtabrutinib (MK-1026) in China Participants With Relapsed or Refractory Hematologic Malignancies (MK-1026-005)
A Phase 1 Clinical Study to Investigate the Safety, Pharmacokinetics and Efficacy of MK-1026 in China Participants With Relapsed or Refractory Hematologic Malignancies
NCT05347225CI-TRIAL-00109879active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of oral nemtabrutinib in Chinese participants at least 18 years of age who have Relapsed/Refractory hematologic malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nemtabrutinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nemtabrutinib
- description
- Participants receive nemtabrutinib at specified dose orally once daily (QD) until progressive disease (PD) or discontinuation.
- interventionNames
- Drug: Nemtabrutinib
Primary outcomes (6)
- measure
- Number of Participants who Experience Adverse Events (AEs)
- timeFrame
- Up to ~ 35 months
- description
- 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.
- measure
- Number of Participants Discontinuing Study Treatment due to AEs
- timeFrame
- Up to ~ 35 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or refractory participants with a diagnosis of B-cell Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) or Waldenström's Macroglobulinemia (WM) who have received no more than 4 prior standard systemic therapies. Participants must have failed or are intolerant to standard therapies and cannot be a candidate for standard salvage regimens and those with low grade lymphoma must be progressing and requiring treatment * Must have received prior systemic treatment before joining this study * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * HBV/HCV viral load undetectable or no history of HBV/HCV * Has adequate organ function * Male participants agree to be abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 30 days after the last dose of the study intervention * Female participant is not a Women of Child Bearing Potential (WOCBP) or is a WOCBP using contraception during the intervention period and for at least 30 days after the last dose of the study intervention Exclusion Criteria: * Has a history of prior cancer within \<3 years, except for adequately treated basal cell or squamous cell carcinoma of the skin, cervical cancer in situ, or other in situ carcinomas * Has active primary tumor involvement of central nervous system (CNS) disease * Has an active infection requiring systemic therapy * Has a known history of Human Immunodeficiency Virus (HIV) infection * Has an uncontrolled illness including but not limited to ongoing symptomatic congestive heart failure (New York Heart Association Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness * Had immunotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product ≤4 weeks prior to treatment initiation * Has any clinically significant gastrointestinal abnormalities that might alter absorption
References
Publications (0)
Data not yet available
No reference posted for this study.