Status:
COMPLETED
HMPL-760 in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Hutchmed
Conditions:
B-Cell Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-760 in Patients with Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Detailed Description
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of HMPL-760 administered orally in subjects with relapsed/refractory B-c...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form (ICF)
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. In the expansion stage, ECOG performance status 0-2
- 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.
- 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.
- Expected survival longer than 24 weeks
Exclusion
- Patients who met any of the following criteria are excluded from the study:
- Lymphoma patients with central nervous system (CNS) or leptomeningeal invasion
- Inadequate organ function of liver and kidney
- 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)
- Any anti-tumor therapy including chemotherapy and radiotherapy within 3 weeks prior to the first dose of study drug
- 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.
- 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
- Prior use of any anti-tumor vaccine
- Prior administration of radioimmunotherapy within 3 months prior to the first dose of study drug
- Any uncontrolled active infection
- History of drug-induced interstitial pneumonia
Key Trial Info
Start Date :
January 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2025
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT05190068
Start Date
January 4 2022
End Date
January 27 2025
Last Update
April 9 2025
Active Locations (22)
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1
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
2
The First Affiliated Hospital of Xiamen University
Xiameng, Fujian, China
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
4
Guangxi Medical University cancer Hospital & Guangxi Cancer Institute
Nanning, Guangxi, China