To evaluate the safety and tolerability of HMPL-653 in patients with advanced solid tumors who have failure of standard of care or can not tolerate standard of care or those with TGCT, and to determine the maximum tolerated dose (MTD) and/or the recommended phase II clinical study dose (RP2D) of HMPL-653 in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
113
Dose-escalation Stage: Several dose levels will be evaluated for HMPL-653. The participants will receive oral HMPL-653 single-dose evaluation and oral HMPL-653 QD continuously treatment in a therapeutic cycle of 28 days until reaching the criteria for the end of treatment. Dose-expansion Stage: The participants will receive HMPL-653 treatment （RP2D）until reaching the criteria for the end of treatment.
Jilin Provincial Cancer Hospital
Changchun, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, China
NOT_YET_RECRUITINGLinyi Cancer Hospital
Linyi, China
NOT_YET_RECRUITINGOccurrence of Dose-Limiting Toxicities(DLTs)
To evaluate the safety and tolerability of HMPL-653 for dose escalation period
Time frame: up to 33 days
Maximum tolerated dose (MTD)
The Maximum tolerated dose of HMPL-653
Time frame: up to 12 months
Recommended phase II dose (RP2D)
Recommended phase II dose of HMPL-653
Time frame: up to 12 months
Pharmacokinetic-Cmax
Peak concentration of Pharmacokinetic
Time frame: up to 9 weeks
Pharmacokinetic-Tmax
Time to peak concentration of Pharmacokinetic
Time frame: up to 9 weeks
Pharmacokinetic-Ctrough
Trough concentration of Pharmacokinetic
Time frame: up to 9 weeks
Pharmacokinetic-t1/2
Terminal elimination half-life of Pharmacokinetic
Time frame: up to 9 weeks
Pharmacokinetic-AUC0-t
Area under the plasma concentration-time curve of Pharmacokinetic
Time frame: up to 9 weeks
Pharmacokinetic-AUC0-∞
Area under the plasma concentration-time curve of Pharmacokinetic
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Henan Cancer Hospital
Zhengzhou, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
NOT_YET_RECRUITINGTime frame: From first dose up to C3D1, estimated up to 9 weeks
Pharmacokinetic-AUC0-τ
Area under the plasma concentration-time curve of Pharmacokinetic
Time frame: up to 9 weeks
Pharmacokinetic-CL/F
Apparent clearance of Pharmacokinetic
Time frame: up to 9 weeks
Pharmacokinetic-Vz/F
Apparent volume of distribution in the terminal phase of Pharmacokinetic
Time frame: up to 9 weeks
Pharmacokinetic-AR
AUC-based accumulation coefficient of Pharmacokinetic
Time frame: up to 9 weeks
Objective response rate (ORR)
The incidence of confirmed complete response or partial response.
Time frame: 12 months
Progression-free survival (PFS)
The time from the first dose of study treatment to PD or death for any reason, whichever comes first.
Time frame: 12 months
Disease control rate (DCR)
The proportion of patients with confirmed CR or PR or stable disease (SD) as the best response, and the duration of SD needs to be ≥6 weeks.
Time frame: 12 months
Time to response (TTR)
The time from the first dose of HMPL-653 to the first objective response.
Time frame: 12 months
Duration of response (DoR)
The time from the first appearance of confirmed CR or PR to PD or death for any reason (whichever comes first), in the patients with objective response.
Time frame: 12 months
Overall survival (OS)
The time from the first dose of study treatment to death for any reason.
Time frame: 24 months