This is a phase II, single arm, multicenter and open-label study to evaluate the efficacy, safety and pharmacokinetic of HMPL-453 in patient with advanced Malignant Mesothelioma
Histologically confirmed patients with advanced malignant mesothelioma that who was failure of the first -line systemic therapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
HMPL-453 tablet
Shanghai Chest Hospital
Shanghai, China
RECRUITINGOverall response rate (ORR)
Evaluating ORR of HMPL-453 in patient with advanced malignant mesothelioma
Time frame: measured up to 6 months after the last subject has been enrolled or all subjects have finished their last PFS follow up, whichever comes first
Disease control rate (DCR)
Evaluating DCR of HMPL-453 in patient with advanced malignant mesothelioma
Time frame: measured up to 6 months after the last subject has been enrolled or all subjects have finished their last PFS follow up, whichever comes first
12 weeks DCR
Evaluating 12 weeks DCR of HMPL-453 in patient with advanced malignant mesothelioma
Time frame: measured on 12 weeks
Time to Response (TTR)
Evaluating TTR of HMPL-453 in patient who achieved partial response or complete response according to RECIST 1.1 or mRECIST 1.1
Time frame: measured on 4 weeks
Duration of response (DoR)
Evaluating DoR of HMPL-453 in patient from subject first achieve a complete remission, or partial remission to patient PD, or death whichever comes first.
Time frame: measured on 30 weeks
12 weeks PFS
Evaluating 12 weeks PFS rate of HMPL-453 in patient with advanced malignant mesothelioma
Time frame: measured on 12 weeks
Progression free survival (PFS)
Evaluating PFS of HMPL-453 in patient with advanced malignant mesothelioma.
Time frame: measured on 20 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Overall survival (OS)
Evaluating OS of HMPL-453 in patient with advanced malignant mesothelioma
Time frame: measured on 60weeks
Adverse Event (AE) of HMPL-453 monitoring
The safety endpoints include adverse events (AEs) and serious adverse events (SAEs). Reporting of safety, extent of exposure, concomitant medications and discontinuation of study therapy will be based on all subjects who received at least 1 dose of treatment. The adverse events will be registered according to NCI CTCAE 5.0.
Time frame: Measured from the first dose to within 30 days after the end of treatment.
Maximum plasma concentration (Cmax) of HMPL-453
Evaluating Cmax of Continuous dosing of HMPL-453 in patient with advanced malignant
Time frame: measured on Cycle 1 day 15 and day 16
The time to Cmax (Tmax) of HMPL-453
Evaluating Tmax of Continuous dosing of HMPL-453 in patient with advanced malignant
Time frame: measured on Cycle 1 day 15 and day 16
The area under the plasma concentration-time curve (AUC) of HMPL-453
Evaluating AUC from 0 to the time of the last measurable concentration of HMPL-453 in patient with advanced malignant
Time frame: measured on Cycle 1 day 15 and day 16