Clinical trial
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Axl Inhibitor FC084CSA in Patients With Advanced Malignant Solid Tumors
Name
FC084-CA-101
Description
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.
Trial arms
Trial start
2023-03-01
Estimated PCD
2024-12-01
Trial end
2025-02-01
Status
Recruiting
Phase
Early phase I
Treatment
FC084CSA tablets
FC084CSA accelerated doses at 100mg QD, and then started the conventional "3+3" design from 200mg QD.
Arms:
FC084CSA
Size
43
Primary endpoint
Determine the Maximum Tolerated Dose (MTD)
Approximately 12 months
Determine the Recommended Phase 2 Dose (RP2D)
Approximately 12 months
Determine dose-limiting toxicity (DLT)
24 days after first dose
Frequency of adverse events (AEs) and SAEs
Approximately 12 months
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 43, 'type': 'ESTIMATED'}}
Updated at
2024-01-31
1 organization
1 abstract
Organization
FindCure Biosciences (ZhongShan)Abstract
Phase I clinical study of FC084CSA, a high selective AXL kinase inhibitor that ameliorates tumor microenvironment and augments the effectivity of immunotherapy.Org: Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy, Italy, Shanghai Pulmonary Hospital, Shanghai, China, School of Medicine, Zhejiang University, Hangzhou, China, Tongji University School of Medicine, Shanghai Henlius Biotech,