Clinical trial NCT06231550: A Study of Axl Inhibitor FC084CSA in Patients With Advanced Malignant Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Malignant Solid Tumors
Lead sponsor: FindCure Biosciences (ZhongShan) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-30
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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:

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.

Primary outcomes:
measure: Determine the Maximum Tolerated Dose (MTD)
timeFrame: Approximately 12 months
measure: Determine the Recommended Phase 2 Dose (RP2D)
timeFrame: Approximately 12 months
measure: Determine dose-limiting toxicity (DLT)
timeFrame: 24 days after first dose
measure: Frequency of adverse events (AEs) and SAEs
timeFrame: Approximately 12 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Approximately 12 months
measure: Disease control rate (DCR)
timeFrame: Approximately 12 months
measure: Progression free survival (PFS)
timeFrame: Approximately 12 months
measure: Pharmacokinetic (PK) Cmax
timeFrame: Approximately 12 months
measure: Pharmacokinetic (PK) Tmax
timeFrame: Approximately 12 months
measure: Pharmacokinetic (PK) AUC 0-t
timeFrame: Approximately 12 months
measure: Pharmacokinetic (PK) AUC 0-∞
timeFrame: Approximately 12 months
measure: Pharmacokinetic (PK) t1/2
timeFrame: Approximately 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
References: