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

Phase 1

Active, not recruiting

• Conditions: Advanced Malignant Solid Tumors
• Interventions: Drug: FC084CSA tablets

• Registration Number: NCT06231550
• Lead Sponsor: FindCure Biosciences (ZhongShan) Co., Ltd.

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.

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-21
• Study First Submitted QC: 2024-01-21
• Study First Posted: 2024-01-30
• Last Update Submitted: 2024-10-13
• Last Update Posted: 2024-10-16
• Primary Completion: 2024-12
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FC084CSA	FC084CSA tablets	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Pharmacokinetic (PK) AUC 0-∞	Approximately 12 months	To investigate the pharmacokinetic (PK) profile of FC084CSA
Pharmacokinetic (PK) t1/2	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
Disease control rate (DCR)	Approximately 12 months	DCR as assessed using RECIST 1.1

Trial Locations

Locations (1)

Shanghai East Hospital; 🇨🇳 Shanghai, Shanghai, China