NCT06990516

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

An Open-label, Multi-center Phase Ib/II Clinical Study of the Combination Regimen of SHR - A1811 Injection in the Treatment of Platinum-sensitive Recurrent Ovarian Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi - center, single - arm, open - label, phase Ib/II clinical trial for dose exploration and efficacy expansion. The aim is to evaluate the tolerability, safety, pharmacokinetic characteristics, and immunogenicity of the combination regimen of SHR - A1811 in the treatment of platinum - sensitive recurrent epithelial ovarian cancer, determine the recommended phase II dose (RP2D) of the combination therapy, and preliminarily assess its efficacy.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-06-01
• Primary completion: 2030-06-01
• Completion: 2035-06-01
• First posted: 2025-05-25
• Last updated: 2025-05-25

Locations

1 site across 1 country: China