Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120, China
NCT Number: NCT06231550
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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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Shanghai, Shanghai Municipality, 200120, China
FC084CSA accelerated doses at 100mg QD, and then started the conventional "3+3" design from 200mg QD.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FC084CSA accelerated doses at 100mg QD, and then started the conventional "3+3" design from 200mg QD.
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.
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.
Time frame: 24 days after first dose
Determine the DLT of FC084CSA
Time frame: Approximately 12 months
To investigate the safety characteristics of FC084CSA
Time frame: Approximately 12 months
To explore the clinical effectiveness. Tumor response based on RECIST 1.1
Time frame: Approximately 12 months
DCR as assessed using RECIST 1.1
Time frame: Approximately 12 months
PFS as assessed using RECIST 1.1
Time frame: Approximately 12 months
To investigate the pharmacokinetic (PK) profile of FC084CSA
Time frame: Approximately 12 months
To investigate the pharmacokinetic (PK) profile of FC084CSA
Time frame: Approximately 12 months
To investigate the pharmacokinetic (PK) profile of FC084CSA
Time frame: Approximately 12 months
To investigate the pharmacokinetic (PK) profile of FC084CSA
Time frame: Approximately 12 months
To investigate the pharmacokinetic (PK) profile of FC084CSA
FindCure Biosciences (ZhongShan) Co., Ltd.
Industry
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
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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