Clinical trial NCT05277454: Clinical Study of HMPL-653 in Treatment of Advanced Malignant Solid Tumors and TGCT
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Malignant Solid Tumors
TGCT
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2022-03-14
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Able to understand and willing to sign the ICF.
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:

1. Toxicity associated with previous antitumor therapy not recovered to ≤CTCAE grade 1；
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.

Primary outcomes:
measure: Occurrence of Dose-Limiting Toxicities(DLTs)
timeFrame: up to 33 days
measure: Maximum tolerated dose (MTD)
timeFrame: up to 12 months
measure: Recommended phase II dose (RP2D)
timeFrame: up to 12 months
Secondary outcomes:
measure: Pharmacokinetic-Cmax
timeFrame: up to 9 weeks
measure: Pharmacokinetic-Tmax
timeFrame: up to 9 weeks
measure: Pharmacokinetic-Ctrough
timeFrame: up to 9 weeks
measure: Pharmacokinetic-t1/2
timeFrame: up to 9 weeks
measure: Pharmacokinetic-AUC0-t
timeFrame: up to 9 weeks
measure: Pharmacokinetic-AUC0-∞
timeFrame: From first dose up to C3D1, estimated up to 9 weeks
measure: Pharmacokinetic-AUC0-τ
timeFrame: up to 9 weeks
measure: Pharmacokinetic-CL/F
timeFrame: up to 9 weeks
measure: Pharmacokinetic-Vz/F
timeFrame: up to 9 weeks
measure: Pharmacokinetic-AR
timeFrame: up to 9 weeks
measure: Objective response rate (ORR)
timeFrame: 12 months
measure: Progression-free survival (PFS)
timeFrame: 12 months
measure: Disease control rate (DCR)
timeFrame: 12 months
measure: Time to response (TTR)
timeFrame: 12 months
measure: Duration of response (DoR)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Chang chun
country: China
facility: Jilin Provincial Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Linyi
country: China
facility: Linyi Cancer Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Jilin Provincial Cancer Hospital
name: Ying Cheng, Prof
role: PRINCIPAL_INVESTIGATOR
References: