MedTrace Logo

SHR - A1811 Versus Chemotherapy for Platinum-resistant Recurrent Epithelial Ovarian Cancer

NCT06990503 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-05-25

No results posted yet for this study

Summary

This study is a randomized, open-label, active-controlled, multicenter phase III clinical trial.

It is planned to enroll 300 subjects with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with HER2 expression. The randomization will be stratified according to the following factors: 1) HER2 immunohistochemistry (IHC) expression status (HER2 IHC 1+ versus HER2 IHC 2+/3+); 2) whether the subject has previously received vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) inhibitors such as bevacizumab (yes versus no).

Subjects will be randomly assigned in a 1:1 ratio to receive either the experimental treatment group (SHR - A1811) or the control treatment group (chemotherapy chosen by the investigator, namely liposomal doxorubicin, paclitaxel, topotecan, or gemcitabine).

Conditions

Interventions

DRUG

SHR-A1811

Injection SHR - A1811 (hereinafter referred to as SHR - A1811) is an antibody - drug conjugate (ADC) targeting the HER2 protein, independently developed by Suzhou Shengdeya Biopharmaceutical Co., Ltd. (hereinafter referred to as the "sponsor"). It is composed of a recombinant humanized anti - HER2 IgG1 monoclonal antibody (SHR - 1805) conjugated with a small molecule component, SHR169106.

DRUG

Chemotherapy

The treatment regimens for the control group are as follows: Liposomal doxorubicin: Administered intravenously on Day 1 of each 4 - week treatment cycle at a dose of 40 mg/m². Paclitaxel: Given intravenously on Days 1, 8, 15, and 22 of each 4 - week treatment cycle at a dose of 80 mg/m² per administration. Topotecan: Intravenously infused on Days 1, 8, and 15 of each 4 - week treatment cycle at a daily dose of 4 mg/m². Gemcitabine: Infused intravenously on Days 1 and 8 of each 3 - week treatment cycle at a daily dose of 1000 mg/m².

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Qinglei Gao · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

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

More Related Trials

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 NCT06990503 on ClinicalTrials.gov