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

NCT ID: NCT06231550

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-03-18

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.

Conditions

Advanced Malignant Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FC084CSA

Group Type: EXPERIMENTAL

FC084CSA tablets

Intervention Type: DRUG

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

Interventions

FC084CSA tablets

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FindCure Biosciences (ZhongShan) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

FC084-CA-101

Identifier Type: -

Identifier Source: org_study_id