This is a phase I clinical study to evaluate safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of Axl inhibitor FC084CSA in patients with advanced malignant solid tumors who have failed standard anti-cancer treatment.
FC084CSA accelerated doses at 100mg QD, and then started the conventional "3+3" design from 200mg QD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
FC084CSA accelerated doses at 100mg QD, and then started the conventional "3+3" design from 200mg QD.
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Determine the Maximum Tolerated Dose (MTD)
The highest dose is defined at which no more than 1 of 3 evaluable participants has had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria and determination by Investigator and Data and Safety Monitoring Committee.
Time frame: Approximately 12 months
Determine the Recommended Phase 2 Dose (RP2D)
The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.
Time frame: Approximately 12 months
Determine dose-limiting toxicity (DLT)
Determine the DLT of FC084CSA
Time frame: 24 days after first dose
Frequency of adverse events (AEs) and SAEs
To investigate the safety characteristics of FC084CSA
Time frame: Approximately 12 months
Objective response rate (ORR)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1
Time frame: Approximately 12 months
Disease control rate (DCR)
DCR as assessed using RECIST 1.1
Time frame: Approximately 12 months
Progression free survival (PFS)
PFS as assessed using RECIST 1.1
Time frame: Approximately 12 months
Pharmacokinetic (PK) Cmax
To investigate the pharmacokinetic (PK) profile of FC084CSA
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Time frame: Approximately 12 months
Pharmacokinetic (PK) Tmax
To investigate the pharmacokinetic (PK) profile of FC084CSA
Time frame: Approximately 12 months
Pharmacokinetic (PK) AUC 0-t
To investigate the pharmacokinetic (PK) profile of FC084CSA
Time frame: Approximately 12 months
Pharmacokinetic (PK) AUC 0-∞
To investigate the pharmacokinetic (PK) profile of FC084CSA
Time frame: Approximately 12 months
Pharmacokinetic (PK) t1/2
To investigate the pharmacokinetic (PK) profile of FC084CSA
Time frame: Approximately 12 months