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

NCT06231550 | Completed Phase 1

• 1 other identifier: FC084-CA-101
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Objective response rate (ORR)

  Approximately 12 months

• Disease control rate (DCR)

  Approximately 12 months

• Progression free survival (PFS)

  Approximately 12 months

• Pharmacokinetic (PK) Cmax

  Approximately 12 months

• Pharmacokinetic (PK) Tmax

  Approximately 12 months

Study Arms (1)

FC084CSA

EXPERIMENTAL

Drug: FC084CSA tablets

Interventions

FC084CSA tablets DRUG

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

FC084CSA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years old male and female.
• Patients with advanced malignant solid tumors who have failed standard treatments.
• According to RECIST 1.1, there is at least one measurable lesion.
• ECOG performance status 0-1.
• 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.

You may not qualify if:

• Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1).
• Received anti-tumor therapy within 4 weeks before enrollment.
• Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period.
• 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.
• Patients with ascites (ascites), pleural effusion (pleural effusion) or pericardial effusion that cannot be controlled by drainage or other methods.
• Central nervous system metastases with clinical symptoms.
• With any situations that the researcher considers inappropriate to participate in this research.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: January 30, 2024
• Study Start: March 1, 2023
• Primary Completion: March 18, 2025
• Study Completion: March 18, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)