A Study of Axl Inhibitor FC084CSA in Patients With Advanced Malignant Solid Tumors

FindCure Biosciences

Status and phase: Completed; Phase 1

Conditions: Advanced Malignant Solid Tumors

Treatments: Drug: FC084CSA tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06231550

FC084-CA-101

Details and patient eligibility

About

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.

Full description

FC084CSA accelerated doses at 100mg QD, and then started the conventional "3+3" design from 200mg QD.

Enrollment: 21 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

FC084CSA

Experimental group

Treatment:

Drug: FC084CSA tablets