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

Advanced Malignant Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06231550
• Other study ID #: FC084-CA-101
• Status: Recruiting
• Phase: Phase 1
• Start date: March 1, 2023
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: FindCure Biosciences (ZhongShan) Co., Ltd.
• Contact: Tingjin Wang
• Phone: 18664044814
• Email: wangtingjin[@]find-cure.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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: ? Blood routine: hemoglobin (HGB) =85 g/L, neutrophil count (ANC) =1.5×10^9/L, platelet count ( PLT) =75×10^9/L; ?Blood 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.

Related Conditions & MeSH terms

• Advanced Malignant Solid Tumors
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
FindCure Biosciences (ZhongShan) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Determine dose-limiting toxicity (DLT)	Determine the DLT of FC084CSA	24 days after first dose
Primary	Frequency of adverse events (AEs) and SAEs	To investigate the safety characteristics of FC084CSA	Approximately 12 months
Secondary	Objective response rate (ORR)	To explore the clinical effectiveness. Tumor response based on RECIST 1.1	Approximately 12 months
Secondary	Disease control rate (DCR)	DCR as assessed using RECIST 1.1	Approximately 12 months
Secondary	Progression free survival (PFS)	PFS as assessed using RECIST 1.1	Approximately 12 months
Secondary	Pharmacokinetic (PK) Cmax	To investigate the pharmacokinetic (PK) profile of FC084CSA	Approximately 12 months
Secondary	Pharmacokinetic (PK) Tmax	To investigate the pharmacokinetic (PK) profile of FC084CSA	Approximately 12 months
Secondary	Pharmacokinetic (PK) AUC 0-t	To investigate the pharmacokinetic (PK) profile of FC084CSA	Approximately 12 months
Secondary	Pharmacokinetic (PK) AUC 0-8	To investigate the pharmacokinetic (PK) profile of FC084CSA	Approximately 12 months
Secondary	Pharmacokinetic (PK) t1/2	To investigate the pharmacokinetic (PK) profile of FC084CSA	Approximately 12 months