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CompletedNCT06231550Updated Aug 7, 2025

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

A Phase 1 interventional study of FC084CSA tablets in Advanced Malignant Solid Tumors, sponsored by FindCure Biosciences (ZhongShan) Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-07.

Sponsored by FindCure Biosciences (ZhongShan) Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Mar 2023, registered Jan 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Advanced Malignant Solid Tumors
03

In context

Lead sponsor

FindCure Biosciences (ZhongShan) Co., Ltd. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    FC084CSA

    Drug: FC084CSA tablets

Interventions

  • DrugFC084CSA tablets

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Approximately 12 months

  2. 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.

    Time frame: Approximately 12 months

  3. Determine dose-limiting toxicity (DLT)

    Determine the DLT of FC084CSA

    Time frame: 24 days after first dose

  4. Frequency of adverse events (AEs) and SAEs

    To investigate the safety characteristics of FC084CSA

    Time frame: Approximately 12 months

Secondary outcomes

  1. Objective response rate (ORR)

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

    Time frame: Approximately 12 months

  2. Disease control rate (DCR)

    DCR as assessed using RECIST 1.1

    Time frame: Approximately 12 months

  3. Progression free survival (PFS)

    PFS as assessed using RECIST 1.1

    Time frame: Approximately 12 months

  4. Pharmacokinetic (PK) Cmax

    To investigate the pharmacokinetic (PK) profile of FC084CSA

    Time frame: Approximately 12 months

  5. Pharmacokinetic (PK) Tmax

    To investigate the pharmacokinetic (PK) profile of FC084CSA

    Time frame: Approximately 12 months

  6. Pharmacokinetic (PK) AUC 0-t

    To investigate the pharmacokinetic (PK) profile of FC084CSA

    Time frame: Approximately 12 months

  7. Pharmacokinetic (PK) AUC 0-∞

    To investigate the pharmacokinetic (PK) profile of FC084CSA

    Time frame: Approximately 12 months

  8. Pharmacokinetic (PK) t1/2

    To investigate the pharmacokinetic (PK) profile of FC084CSA

    Time frame: Approximately 12 months

07

Study locations

1 site
  • Shanghai East Hospital
    Shanghai, Shanghai Municipality 200120, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06231550
Lead sponsor
FindCure Biosciences (ZhongShan) Co., Ltd.
Responsible party
Sponsor
First posted
Jan 30, 2024
Start date
Mar 1, 2023
Primary completion
Mar 18, 2025
Completion
Mar 18, 2025
Last update
Aug 7, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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