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

NCT06990516 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-05-25

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Qinglei Gao · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2030-06-01
Completion
2035-06-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06990516 on ClinicalTrials.gov