This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in combination with FOLFIRI in patients with previously treated metastatic colorectal cancer. This study includes two stages. Stage 1 is the dose-escalation stage. Once the maximum tolerated dose (MTD) of Sevacizumab has been established, additional patients will be enrolled in the cohort-expansion stage (Stage 2).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
escalating doses of Sevacizumab : 3mg/kg,4mg/kg,5mg/kg
Irinotecan: IV solution, IV over 90 minutes, 180 mg/m², Every 14 days, Until disease progression/toxicity
5-FU: IV solution, IV bolus over 2-4 minutes, 400 mg/m²; IV infusion over 46 hours, 2400 mg/m²; Every 14 days, Until disease progression/toxicity
Leucovorin: IV solution, IV over 2 hours, 400 mg/m², Every 14 days, Until disease progression/toxicity
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGThe First Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
RECRUITINGMaximum Tolerated Dose (MTD)
Time frame: up to 56 days
Adverse Events (NCI-CTC 4.0)
Time frame: 28 days after the last dose
Plasma pharmacokinetics (PK) parameters for Sevacizumab
Time frame: Cycle 1(Day3, Day4, Day7, Day10, Day13); Cycle 2-4(Day1);Cycle 4(Day1, Day2, Day5, Day8 ,Day11)
Plasma pharmacokinetics (PK) parameters (Cmax, Tmax, AUC, T1/2) for Irinotecan and its major metabolite SN-38
Time frame: Day1, Day2, Day3, Day15, Day16, Day17
Plasma pharmacokinetics (PK) parameters for 5-FU
Time frame: Day1, Day3, Day15, Day17
Potential biomarkers, including VEGF and ADA
Time frame: VEGF:Cycle 1(Day3, Day4, Day7, Day10, Day13); Cycle 2-4(Day1);Cycle 4(Day1, Day2, Day5, Day8, Day11); ADA : within 15 minutes before each Sevacizumab administration
Objective Response Rate (ORR)
Time frame: up to 3 years from date of registration
Disease Control Rate (DCR)
Time frame: up to 3 years from date of registration
Progression Free Survival (PFS)
Time frame: up to 3 years from date of registration
Overall Survival (OS)
Time frame: up to 3 years from date of registration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.