Status:
ACTIVE_NOT_RECRUITING
A Study of Nemtabrutinib (MK-1026) in China Participants With Relapsed or Refractory Hematologic Malignancies (MK-1026-005)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hematological Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05347225
Start Date
June 9 2022
End Date
April 30 2027
Last Update
August 15 2025
Active Locations (5)
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1
Guangdong Provincial People's Hospital-hematology department ( Site 1002)
Guangzhou, Guangdong, China, 510080
2
SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal medicine ( Site 1007)
Guangzhou, Guangdong, China, 511400
3
Henan Cancer Hospital-hematology department ( Site 1003)
Zhengzhou, Henan, China, 450008
4
Hunan Cancer Hospital ( Site 1004)
Changsha, Hunan, China, 410013