HMPL-760 in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
NCT ID: NCT05190068
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
89 participants
INTERVENTIONAL
2022-01-04
2025-01-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Relapsed/refractory B-NHL
The starting dose of HMPL-760 is initially set as 50 mg, and then the doses of 100 mg, 200 mg, 300 mg, and 400 mg are escalated successively (this dose gradient is assumed).
HMPL-760 was administered continuously as a single agent orally every day in sequential 28-day cycles.
HMPL-760
HMPL-760 was administered continuously as a single agent orally every day in sequential 28-day cycles.
Interventions
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HMPL-760
HMPL-760 was administered continuously as a single agent orally every day in sequential 28-day cycles.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 years
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. In the expansion stage, ECOG performance status 0-2
4. Relapsed/refractory patients with histologically confirmed lymphoma
* CLL confirmed by cytology (flow cytometry)
* LPL/WM diagnosed by relevant tests including serum, bone marrow, and pathological examinations.
5. Except for CLL and WM, at least one bidimensionally measurable lesion is required by CT scan, which means the largest diameter of lymph node lesions \>1.5 cm or extranodal lesions \>1.0 cm; For lesions that cannot be well displayed by CT due to anatomical location (such as limb or soft tissue lesions), MRI measurement can be used.
6. Expected survival longer than 24 weeks
Exclusion Criteria
1. Lymphoma patients with central nervous system (CNS) or leptomeningeal invasion
2. Inadequate organ function of liver and kidney
3. Carcinoma in situ of the breast History of liver disease, including cirrhosis, alcoholism, or currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
4. Any anti-tumor therapy including chemotherapy and radiotherapy within 3 weeks prior to the first dose of study drug
5. Within 7 days or approximately 5 half-lives (whichever is longer) prior to the first dose of the investigational drug, received any corticosteroids or approved small molecule targeted anti-cancer therapies.
6. Any monoclonal antibody used for anti-tumor therapy within 4 weeks or 2 half-lives prior to the first dose of study drug, whichever is longer
7. Prior use of any anti-tumor vaccine
8. Prior administration of radioimmunotherapy within 3 months prior to the first dose of study drug
9. Any uncontrolled active infection
10. History of drug-induced interstitial pneumonia
18 Years
ALL
No
Sponsors
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Hutchmed
INDUSTRY
Responsible Party
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Principal Investigators
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Weili Zhao, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Locations
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Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiameng, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangxi Medical University cancer Hospital & Guangxi Cancer Institute
Nanning, Guangxi, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Chenzhou First People's Hospital
Chenzhou, Hunan, China
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Harbin Medical University Cancer Hospital
Harbin, Longjiang Hei, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Chongqing university cancer hospital
Chongqing, , China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Other Identifiers
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2021-760-00CH1
Identifier Type: -
Identifier Source: org_study_id
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