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Completed

NCT Number: NCT06231550

A Study 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

FC084CSA tablets

Drug

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

Primary outcomes

  1. Determine the Maximum Tolerated Dose (MTD)

    Time frame: 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.

  2. Determine the Recommended Phase 2 Dose (RP2D)

    Time frame: Approximately 12 months

    The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.

  3. Determine dose-limiting toxicity (DLT)

    Time frame: 24 days after first dose

    Determine the DLT of FC084CSA

  4. Frequency of adverse events (AEs) and SAEs

    Time frame: Approximately 12 months

    To investigate the safety characteristics of FC084CSA

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: Approximately 12 months

    To explore the clinical effectiveness. Tumor response based on RECIST 1.1

  2. Disease control rate (DCR)

    Time frame: Approximately 12 months

    DCR as assessed using RECIST 1.1

  3. Progression free survival (PFS)

    Time frame: Approximately 12 months

    PFS as assessed using RECIST 1.1

  4. Pharmacokinetic (PK) Cmax

    Time frame: Approximately 12 months

    To investigate the pharmacokinetic (PK) profile of FC084CSA

  5. Pharmacokinetic (PK) Tmax

    Time frame: Approximately 12 months

    To investigate the pharmacokinetic (PK) profile of FC084CSA

  6. Pharmacokinetic (PK) AUC 0-t

    Time frame: Approximately 12 months

    To investigate the pharmacokinetic (PK) profile of FC084CSA

  7. Pharmacokinetic (PK) AUC 0-∞

    Time frame: Approximately 12 months

    To investigate the pharmacokinetic (PK) profile of FC084CSA

  8. Pharmacokinetic (PK) t1/2

    Time frame: Approximately 12 months

    To investigate the pharmacokinetic (PK) profile of FC084CSA

Sponsors and collaborators

Lead sponsor

FindCure Biosciences (ZhongShan) Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2024
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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