An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-760 in patients with previously treated CLL/SLL or NHL
HMPL-760 is a highly potent, selective, and reversible inhibitor against BTK, which would be studied in B-cell malignancy carrying either BTK(WT) or BTK(C481S). This is a phase 1, open-label, multicenter, single-arm study to evaluate safety, tolerability, PK, PD, and preliminary efficacy of HMPL-760 in patients with previously treated CLL/SLL or NHL The study consists of 2 parts: Part 1- Dose Escalation to determine MTD and/or RP2D of HMPL-760 Part 2- Dose Expansion to characterize the safety and tolerability of HMPL-760
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Administered orally QD for 28-day cycles
Incidence of DLTs
Adverse event (AE) that meets protocol defined DLT criteria during dose escalation
Time frame: Up to 28 days after first dose of study drug
Incidence of AEs/SAEs
Any untoward medical occurrence associated with the use of study drug
Time frame: From 1st dose to within 30 days of last dose
MTD
To evaluate maximum tolerated dose of HMPL-760 in subjects, if reached
Time frame: From 1st dose to within 30 days of last dose
RP2D
To determine recommended phase 2 dose of HMPL-760 in subjects
Time frame: From 1st dose to within 30 days of last dose
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects achieving partial response and better response during the study
Time frame: From 1st dose of study drug to the time of progressive disease, assessed up to 36 months
Duration of Response (DoR)
DoR is defined as the time between the initial response to therapy and subsequent disease progression or relapse.
Time frame: From first dose of study drug to the time of progressive disease, assessed up to 36 months
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of subjects achieving objective response or stable disease
Time frame: From 1st dose of study drug to the time of progressive disease, assessed up to 36 months
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Innovative Clinical Research
Anaheim, California, United States
Emory University Hospital
Atlanta, Georgia, United States
Tulane Cancer Center
New Orleans, Louisiana, United States
Johns Hopkins Clinical Research Center
Baltimore, Maryland, United States
AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company
Kansas City, Missouri, United States
Center For Advanced Medicine
St Louis, Missouri, United States
Summit Medical Group
Florham Park, New Jersey, United States
New York University Langone Med Center. Lab
New York, New York, United States
Clinical Research Alliance
Westbury, New York, United States
Renovatio Clinical
El Paso, Texas, United States
...and 26 more locations
Progression-free Survival (PFS)
PFS is defined as survival without progression of the disease
Time frame: From 1st dose of study drug to the time of progressive disease, assessed up to 36 months
Maximum Plasma Concentration [Cmax]
To determine the maximum observed plasma concentration of HMPL-760
Time frame: From 1st dose to within 30 days of last dose
Chemokines
To observe blood plasma concentrations of chemokines such as CCL22 and CCL3
Time frame: From 1st dose to within 30 days of last dose
Phospho-BTK
To observe the whole blood concentrations of phospho-BTK
Time frame: From 1st dose to within 30 days of last dose