This is an open-label, multicenter Phase II clinical study conducted in subjects with recurrent ovarian cancer.
The study aims to evaluate the safety/tolerability, pharmacokinetics, and preliminary efficacy of SYS6041 in combination with other agents in subjects with recurrent ovarian cancer. Eligible subjects will receive SYS6041 in combination with different agents (carboplatin, paclitaxel, bevacizumab, enlonstobart) . Each treatment cycle lasting 3 weeks, until disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
171
SYS6041: RP2D dose, ivgtt, Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
SYS6041: RP2D dose, ivgtt, Q3W Carboplatin: AUC5, ivgtt. Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
Paclitaxel:175mg/m2, ivgtt, Q3W Carboplatin: AUC5, ivgtt. Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGThe incidence of dose-limiting toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
AEs and SAEs
Frequency and severity of AEs and SAEs (according to NCI-CTCAE 6.0);
Time frame: Baseline up to 30 days post last dose
Recommended Phase 2 Dose (RP2D )
Time frame: Up to approximately 3 years
Objective Response Rate (ORR)
Time frame: Up to approximately 3 years
Disease control rate (DCR)
Time frame: Up to approximately 3 years
Duration of Response (DoR)
Time frame: Up to approximately 3 years
Progression-Free-Survival (PFS)
Time frame: Up to approximately 3 years
Overall survival (OS)
Time frame: Up to approximately 3 years
Expression level of tumor markers
Time frame: Up to approximately 3 years
Maximum Plasma Concentration( Cmax)
Time frame: Up to approximately 3 years
Time to Maximum Plasma Concentration (Tmax)
Time frame: Up to approximately 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
SYS6041: RP2D dose, ivgtt, Q3W Enlonstobart:360mg, ivgtt, Q3W Bevacizumab: 15mg/kg, ivgtt, Q3W
Area Under the Serum Concentration Time Curve ( AUC)
Time frame: Up to approximately 3 years
Elimination half-life (t1/2)
Time frame: Up to approximately 3 years
Anti-Drug Antibody(ADA)
Time frame: Up to approximately 3 years