Advanced Malignant Solid TumorsPhase 1NCT06231550
A Study of Axl Inhibitor FC084CSA in Patients With Advanced Malignant Solid Tumors
A Phase 1 study testing FC084CSA tablets in people with Advanced Malignant Solid Tumors, run by FindCure Biosciences (ZhongShan) Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- FC084CSA tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 18 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- FC084CSA tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FC084CSA tabletsDrug
FC084CSA accelerated doses at 100mg QD, and then started the conventional "3+3" design from 200mg QD.
| Study group | Role | What they receive |
|---|---|---|
| FC084CSA | Experimental | Not described Receives: Drug: FC084CSA tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately 12 months
Determine dose-limiting toxicity (DLT)
Determine the DLT of FC084CSA
Measured: 24 days after first dose
Frequency of adverse events (AEs) and SAEs
To investigate the safety characteristics of FC084CSA
Measured: Approximately 12 months
Secondary outcomes (8)
Objective response rate (ORR)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1
Measured: Approximately 12 months
Disease control rate (DCR)
DCR as assessed using RECIST 1.1
Measured: Approximately 12 months
Progression free survival (PFS)
PFS as assessed using RECIST 1.1
Measured: Approximately 12 months
Pharmacokinetic (PK) Cmax
To investigate the pharmacokinetic (PK) profile of FC084CSA
Measured: Approximately 12 months
Pharmacokinetic (PK) Tmax
To investigate the pharmacokinetic (PK) profile of FC084CSA
Measured: Approximately 12 months
Pharmacokinetic (PK) AUC 0-t
To investigate the pharmacokinetic (PK) profile of FC084CSA
Measured: Approximately 12 months
Pharmacokinetic (PK) AUC 0-∞
To investigate the pharmacokinetic (PK) profile of FC084CSA
Measured: Approximately 12 months
Pharmacokinetic (PK) t1/2
To investigate the pharmacokinetic (PK) profile of FC084CSA
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Mar 2023
- Primary completion18 Mar 2025
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- FindCure Biosciences (ZhongShan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231550
- Sponsor's protocol ID
- FC084-CA-101
- Status last verified
- Aug 2025
- First submitted
- 21 Jan 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06231550
- Acronym / sponsor ID
- FC084-CA-101
- Conditions
- Advanced Malignant Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- FindCure Biosciences (ZhongShan) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
FC084CSA accelerated doses at 100mg QD, and then started the conventional "3+3" design from 200mg QD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FC084CSA | Experimental | Drug: FC084CSA tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FC084CSA tabletsFC084CSA accelerated doses at 100mg QD, and then started the conventional "3+3" design from 200mg QD. | Drug | FC084CSA |
Primary outcome
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.
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.
Determine dose-limiting toxicity (DLT)
Time frame: 24 days after first dose
Determine the DLT of FC084CSA
Frequency of adverse events (AEs) and SAEs
Time frame: Approximately 12 months
To investigate the safety characteristics of FC084CSA
8 secondary outcomes
Objective response rate (ORR)
Time frame: Approximately 12 months
Disease control rate (DCR)
Time frame: Approximately 12 months
Progression free survival (PFS)
Time frame: Approximately 12 months
Pharmacokinetic (PK) Cmax
Time frame: Approximately 12 months
Pharmacokinetic (PK) Tmax
Time frame: Approximately 12 months
Pharmacokinetic (PK) AUC 0-t
Time frame: Approximately 12 months
Pharmacokinetic (PK) AUC 0-∞
Time frame: Approximately 12 months
Pharmacokinetic (PK) t1/2
Time frame: Approximately 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FC084CSA tablets in people with Advanced Malignant Solid Tumors, run by FindCure Biosciences (ZhongShan) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the Maximum Tolerated Dose (MTD) (time frame: Approximately 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.