Clinical Study of HMPL-653 in Treatment of Advanced Malignant Solid Tumors and TGCT
NCT05277454 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 113
Last updated 2022-03-14
Summary
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.
Conditions
- Advanced Malignant Solid Tumors
- TGCT
Interventions
- DRUG
-
HMPL-653
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.
Sponsors & Collaborators
-
Hutchison Medipharma Limited
lead INDUSTRY
Principal Investigators
-
Ying Cheng, Prof · Jilin Provincial Cancer Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-18
- Primary Completion
- 2024-06-28
- Completion
- 2025-04-14
Countries
- China
Study Locations
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