Advanced Malignant Solid Tumors
Conditions
Brief summary
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.
Detailed description
FC084CSA accelerated doses at 100mg QD, and then started the conventional 3+3 design from 200mg QD.
Interventions
DRUGFC084CSA tablets
FC084CSA accelerated doses at 100mg QD, and then started the conventional 3+3 design from 200mg QD.
Sponsors
FindCure Biosciences (ZhongShan) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 75 years old male and female. 2. Patients with advanced malignant solid tumors who have failed standard treatments. 3. According to RECIST 1.1, there is at least one measurable lesion. 4. ECOG performance status 0-1. 5. Laboratory examination should meet: ① Blood routine: hemoglobin (HGB) ≥85 g/L, neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ( PLT) ≥75×10\^9/L; ②Blood biochemistry: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN, serum creatinine ( Cr)≤1.5×ULN or calculate the creatinine clearance ≥50 mL/min according to the Cockcroft-Gault formula method.
Exclusion criteria
1. Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1). 2. Received anti-tumor therapy within 4 weeks before enrollment. 3. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period. 4. Have undergone surgery within 4 weeks before enrollment, and the investigator believes that the patient's state has not recovered to the point where the study can be started. 5. Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods. 6. Central nervous system metastases with clinical symptoms. 7. With any situations that the researcher considers inappropriate to participate in this research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Maximum Tolerated Dose (MTD) | Approximately 12 months | 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. |
| Determine the Recommended Phase 2 Dose (RP2D) | Approximately 12 months | The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD. |
| Determine dose-limiting toxicity (DLT) | 24 days after first dose | Determine the DLT of FC084CSA |
| Frequency of adverse events (AEs) and SAEs | Approximately 12 months | To investigate the safety characteristics of FC084CSA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Tmax | Approximately 12 months | To investigate the pharmacokinetic (PK) profile of FC084CSA |
| Pharmacokinetic (PK) AUC 0-t | Approximately 12 months | To investigate the pharmacokinetic (PK) profile of FC084CSA |
| Objective response rate (ORR) | Approximately 12 months | To explore the clinical effectiveness. Tumor response based on RECIST 1.1 |
| Pharmacokinetic (PK) t1/2 | Approximately 12 months | To investigate the pharmacokinetic (PK) profile of FC084CSA |
| Pharmacokinetic (PK) AUC 0-∞ | Approximately 12 months | To investigate the pharmacokinetic (PK) profile of FC084CSA |
| Disease control rate (DCR) | Approximately 12 months | DCR as assessed using RECIST 1.1 |
| Progression free survival (PFS) | Approximately 12 months | PFS as assessed using RECIST 1.1 |
| Pharmacokinetic (PK) Cmax | Approximately 12 months | To investigate the pharmacokinetic (PK) profile of FC084CSA |
Countries
China
Outcome results
None listed