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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Malignant Solid Tumors
• Intervention / Treatment: Drug: FC084CSA tablets

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 43
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Tingjin Wang; Phone Number: 18664044814; Email: wangtingjin@find-cure.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Caicun Zhou; Phone Number: 13301825532; Email: caicunzhoudr@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FC084CSA	Drug: FC084CSA tablets; FC084CSA accelerated doses at 100mg QD, and then started the conventional "3+3" design from 200mg QD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the Maximum Tolerated Dose (MTD)	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.	Approximately 12 months
Determine the Recommended Phase 2 Dose (RP2D)	The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.	Approximately 12 months
Determine dose-limiting toxicity (DLT)	Determine the DLT of FC084CSA	24 days after first dose
Frequency of adverse events (AEs) and SAEs	To investigate the safety characteristics of FC084CSA	Approximately 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	To explore the clinical effectiveness. Tumor response based on RECIST 1.1	Approximately 12 months
Disease control rate (DCR)	DCR as assessed using RECIST 1.1	Approximately 12 months
Progression free survival (PFS)	PFS as assessed using RECIST 1.1	Approximately 12 months
Pharmacokinetic (PK) Cmax	To investigate the pharmacokinetic (PK) profile of FC084CSA	Approximately 12 months
Pharmacokinetic (PK) Tmax	To investigate the pharmacokinetic (PK) profile of FC084CSA	Approximately 12 months
Pharmacokinetic (PK) AUC 0-t	To investigate the pharmacokinetic (PK) profile of FC084CSA	Approximately 12 months
Pharmacokinetic (PK) AUC 0-∞	To investigate the pharmacokinetic (PK) profile of FC084CSA	Approximately 12 months
Pharmacokinetic (PK) t1/2	To investigate the pharmacokinetic (PK) profile of FC084CSA	Approximately 12 months

Collaborators and Investigators

• Sponsor: FindCure Biosciences (ZhongShan) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: January 21, 2024
• First Submitted That Met QC Criteria: January 21, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: FC084-CA-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No