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
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-cell non-Hodgkin lymphoma (B-NHL). Patients with relapsed/refractory B-NHL, including chronic lymphocytic leukemia/small cell lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular cell lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and lymphoplasmacytic/macroglobulinemia (LPL/WM).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
HMPL-760 was administered continuously as a single agent orally every day in sequential 28-day cycles.
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
DLTs
Number of subjects with Dose Limiting Toxicities (DLTs) with relapsed/refractory B-cell non-Hodgkin's lymphoma relapsed/refractory B-cell non-Hodgkin's lymphoma
Time frame: Up to 28 days after first dose of study drug.
Safety and Tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Baseline up to the end of study
Objective response rate (ORR)
Defined as the proportion of patients with CR/Partial response (PR)/CR with incomplete hematologic recovery (CRi)/ partial response with lymphocytosis (PR-L)
Time frame: Baseline up to 6 months after the last patient was enrolled
Complete response rate (CR rate)
Defined as the proportion of patients with CR/CRi
Time frame: Baseline up to 6 months after the last patient was enrolled
Progression-free survival (PFS)
Defined as the time from the first dose of HMPL-760 to occurrence of Progressive disease (PD) or death, whichever comes first
Time frame: Baseline up to 6 months after the last patient was enrolled
Time to Response (TTR)
Defined as the time from the first dose of HMPL-760 to the first objective response
Time frame: Baseline up to 6 months after the last patient was enrolled
Clinical Benefit Rate (CBR)
Defined as the proportion of patients with CR/CRi, PR/PR-L and Stable disease (SD)
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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
...and 12 more locations
Time frame: Baseline up to 6 months after the last patient was enrolled
Duration of Response (DoR)
Defined as the time from the initial objective response to disease recurrence, progression or death
Time frame: Baseline up to 6 months after the last patient was enrolled
Overall Survival (OS)
Defined as the time from the first dose to death due to any cause
Time frame: Baseline up to 6 months after the last patient was enrolled