Clinical Study of HMPL-653 in Treatment of Advanced Malignant Solid Tumors and TGCT
NCT ID: NCT05277454
Last Updated: 2022-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
113 participants
INTERVENTIONAL
2022-01-18
2025-04-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HMPL-653 open-label treatment arm
Dose-escalation Stage:
Participants will be treated with escalating doses of HMPL-653 to determine the MTD and RP2D.
Dose-expansion Stage:
Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of HMPL-653 in TGCT and specific advanced solid tumors.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Aged 18 to 75 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy at least 12 weeks.
5. Adequate bone marrow, liver and kidney function.
Exclusion Criteria
2. Previous treatment with anti-CSF1R therapy and have progressive disease;
3. Receiving approved systematic antitumor therapy or in the treatment period of other interventional clinical study within 4 weeks prior to the first dose.
4. Patients with central nervous system (CNS) malignant tumor or malignant solid tumor with known CNS metastasis;
5. Pregnant or lactating women.
18 Years
75 Years
ALL
No
Sponsors
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Hutchison Medipharma Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Ying Cheng, Prof
Role: PRINCIPAL_INVESTIGATOR
Jilin Provincial Cancer Hospital
Locations
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Jilin Provincial Cancer Hospital
Changchun, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Linyi Cancer Hospital
Linyi, , China
Henan Cancer Hospital
Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Ying Cheng, Prof
Role: primary
Yanqiao Zhang, Prof
Role: primary
Jianhua Shi, Prof
Role: primary
Suxia Luo, Prof
Role: primary
Weijie Zhang, Prof
Role: primary
Other Identifiers
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2021-653-00CH1
Identifier Type: -
Identifier Source: org_study_id
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