Clinical Study of HMPL-653 in Treatment of Advanced Malignant Solid Tumors and TGCT
A Multicenter, Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-653 in Treatment of Patients With Advanced Malignant Solid Tumors and Tenosynovial Giant Cell Tumor
1 other identifier
interventional
113
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2022
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 18, 2022
CompletedFirst Submitted
Initial submission to the registry
February 6, 2022
CompletedFirst Posted
Study publicly available on registry
March 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2025
CompletedMarch 14, 2022
January 1, 2022
2.4 years
February 6, 2022
March 11, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Occurrence of Dose-Limiting Toxicities(DLTs)
To evaluate the safety and tolerability of HMPL-653 for dose escalation period
up to 33 days
Maximum tolerated dose (MTD)
The Maximum tolerated dose of HMPL-653
up to 12 months
Recommended phase II dose (RP2D)
Recommended phase II dose of HMPL-653
up to 12 months
Secondary Outcomes (16)
Pharmacokinetic-Cmax
up to 9 weeks
Pharmacokinetic-Tmax
up to 9 weeks
Pharmacokinetic-Ctrough
up to 9 weeks
Pharmacokinetic-t1/2
up to 9 weeks
Pharmacokinetic-AUC0-t
up to 9 weeks
- +11 more secondary outcomes
Study Arms (1)
HMPL-653 open-label treatment arm
EXPERIMENTALDose-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.
Interventions
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
You may qualify if:
- Able to understand and willing to sign the ICF.
- Aged 18 to 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy at least 12 weeks.
- Adequate bone marrow, liver and kidney function.
You may not qualify if:
- Toxicity associated with previous antitumor therapy not recovered to ≤CTCAE grade 1；
- Previous treatment with anti-CSF1R therapy and have progressive disease;
- Receiving approved systematic antitumor therapy or in the treatment period of other interventional clinical study within 4 weeks prior to the first dose.
- Patients with central nervous system (CNS) malignant tumor or malignant solid tumor with known CNS metastasis;
- Pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Cheng, Prof
Jilin Provincial Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2022
First Posted
March 14, 2022
Study Start
January 18, 2022
Primary Completion
June 28, 2024
Study Completion
April 14, 2025
Last Updated
March 14, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share