SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

June 1, 2030

Study Completion Date

June 1, 2035

Conditions
Ovarian Cancer
Interventions
DRUG

SHR-A1811

"Dose: 3.2 mg/kg, 4 mg/kg, or 4.8 mg/kg, administered intravenously (IV) every 3 weeks (Q3W).~Infusion Duration:~First infusion: 90 ± 10 minutes. Subsequent infusions: May be shortened to approximately 30 minutes (minimum 20 minutes, maximum 60 minutes, including flush phase) if no infusion-related reactions occur after the first dose."

DRUG

Carboplatin

"Dose: Area Under the Curve (AUC) 5 mg/mL/min, administered IV Q3W.~Infusion Duration:~Should be completed within 30-60 minutes (including flush phase).~Treatment Schedule:~Up to 6 treatment cycles, with each cycle lasting 3 weeks."

DRUG

Oxaliplatin

"Dose: 85 mg/m², administered IV Q3W.~Infusion Duration:~Should be infused over \>120 minutes (including flush phase).~Treatment Schedule:~Up to 6 treatment cycles, with each cycle lasting 3 weeks."

DRUG

Bevacizumab

"Dose: 15 mg/kg, administered IV Q3W.~Infusion Duration:~First dose: 90 minutes. Second dose: If the first infusion is well-tolerated, may be shortened to 60 minutes.~Subsequent doses: If the 60-minute infusion is well-tolerated, all following infusions may be administered over 30 minutes (including flush phase)."

Trial Locations (1)

430030

Tongji Hospital, Wuhan

All Listed Sponsors
lead

Tongji Hospital

OTHER