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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FC084CSA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FC084CSA tablets | Drug | FC084CSA accelerated doses at 100mg QD, and then started the conventional "3+3" design from 200mg QD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Approximately 12 months |
| Determine dose-limiting toxicity (DLT) | Determine the DLT of FC084CSA | 24 days after first dose |
| Frequency of adverse events (AEs) and SAEs | To investigate the safety characteristics of FC084CSA | Approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | To explore the clinical effectiveness. Tumor response based on RECIST 1.1 | Approximately 12 months |
| Disease control rate (DCR) | DCR as assessed using RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Shanghai | Shanghai Municipality | 200120 | China |
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| Approximately 12 months |
| Progression free survival (PFS) | PFS as assessed using RECIST 1.1 | Approximately 12 months |
| Pharmacokinetic (PK) Cmax | To investigate the pharmacokinetic (PK) profile of FC084CSA | Approximately 12 months |
| Pharmacokinetic (PK) Tmax | To investigate the pharmacokinetic (PK) profile of FC084CSA | Approximately 12 months |
| Pharmacokinetic (PK) AUC 0-t | To investigate the pharmacokinetic (PK) profile of FC084CSA | Approximately 12 months |
| Pharmacokinetic (PK) AUC 0-∞ | To investigate the pharmacokinetic (PK) profile of FC084CSA | Approximately 12 months |
| Pharmacokinetic (PK) t1/2 | To investigate the pharmacokinetic (PK) profile of FC084CSA | Approximately 12 months |