A Study of Nemtabrutinib (MK-1026) in China Participants With Relapsed or Refractory Hematologic Malignancies (MK-1026-005)

NCT05347225 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 1026-005MK-1026-005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 5

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 hematologic malignancies.

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (6)

• 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 ~ 35 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 ~ 35 months

• Maximum Concentration (Cmax) of Nemtabrutinib

  Cmax is the maximum concentration of nemtabrutinib observed in plasma. Blood samples collected at designated timepoints will be used to determine Cmax.

  Day 1 of Cycles 1 and 2: Pre-dose,1, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 hours post-dose (up to ~57 days). Each cycle is 28 days

• Minimum Concentration (Cmin) of Nemtabrutinib

  Cmin is the minimum concentration of nemtabrutinib observed in plasma. Blood samples collected at designated timepoints will be used to determine Cmin.

  Day 1 of Cycles 1 and 2: Pre-dose,1, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 hours post-dose (up to ~57 days). Each cycle is 28 days

• Area Under the Plasma Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Nemtabrutinib

  AUC0-24 is the area under the curve of plasma concentration of nemtabrutinib from time 0 to 24 hours. Blood samples collected at designated timepoints will be used to determine AUC0-24.

  Day 1 of Cycles 1 and 2: Pre-dose,1, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 hours post-dose (up to ~57 days). Each cycle is 28 days

• Time to Maximum Concentration (Tmax) of Nemtabrutinib

  Tmax is the time to reach maximum concentration of nemtabrutinib. Blood samples collected at designated timepoints will be used to determine Tmax.

  Day 1 of Cycles 1 and 2: Pre-dose,1, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 hours post-dose (up to ~57 days). Each cycle is 28 days

Secondary Outcomes (6)

• Objective Response Rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by the Investigator

  Up to ~ 35 months

• ORR per International Workshop on Waldenström's Macroglobulinemia (IWWM) Criteria 2014 as Assessed by the Investigator

  Up to ~ 35 months

• ORR per Lugano Criteria 2014 as Assessed by the Investigator

  Up to ~ 35 months

• Duration of Response (DOR) per iwCLL Criteria 2018 as Assessed by the Investigator

  Up to ~ 35 months

• DOR per IWWM Criteria 2014 as Assessed by the Investigator

  Up to ~ 35 months

Study Arms (1)

Nemtabrutinib

EXPERIMENTAL

Participants receive nemtabrutinib at specified dose orally once daily (QD) until progressive disease (PD) or discontinuation.

Drug: Nemtabrutinib

Interventions

Nemtabrutinib DRUG

Nemtabrutinib tablets will be administered orally QD.

Also known as: MK-1026, ARQ 531

Nemtabrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (5)

Guangdong Provincial People's Hospital-hematology department ( Site 1002)

Guangzhou, Guangdong, 510080, China

Location

SUN YAT-SEN UNIVERSITY CANCER CENTRE-Internal medicine ( Site 1007)

Guangzhou, Guangdong, 511400, China

Location

Henan Cancer Hospital-hematology department ( Site 1003)

Zhengzhou, Henan, 450008, China

Location

Hunan Cancer Hospital ( Site 1004)

Changsha, Hunan, 410013, China

Location

Institute of hematology&blood disease hospital-Hematology ( Site 1001)

Tianjin, Tianjin Municipality, 301636, China

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

ARQ531

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 26, 2022
• Study Start: June 9, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 29, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (5)