A Study of SHR-A1811 in Subjects With Ovarian Cancer

April 15, 2026 updated by: Jiangsu HengRui Medicine Co., Ltd.

An Open-label, Randomized, Multicenter Phase III Clinical Trial of SHR-A1811 Versus Investigator-selected Chemotherapy for Platinum-resistant Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

This is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Ding Ma
        • Principal Investigator:
          • Qinglei Gao
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Principal Investigator:
          • Beihua Kong
        • Principal Investigator:
          • Kun Song
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The subjects voluntarily joined the study and signed the Informed consent forms (ICF).
  2. Measurable disease, as defined by RECIST v1.1.
  3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
  4. Life expectancy ≥ 12 weeks.

Exclusion Criteria:

  1. Symptomatic, untreated or active central nervous system metastases.
  2. Have uncontrolled or severe cardiovascular disease.
  3. With any active autoimmune disease or history of autoimmune disease.
  4. Patients with active hepatitis B or hepatitis C.
  5. Severe infections prior to initiation of study treatment.
  6. Patients with active tuberculosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-A1811 group
Drug: SHR-A1811
SHR-A1811.
Active Comparator: Chemotherapy group
Drug: Paclitaxel Injection
Paclitaxel Injection.
Drug: Gemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for Injection.
Drug: Doxorubicin Hydrochloride Liposome Injection
Doxorubicin Hydrochloride Liposome Injection.
Drug: Topotecan Hydrochloride for Injection
Topotecan Hydrochloride for Injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS)
Time Frame: From day 1 to 10 months.
From day 1 to 10 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: From day 1 to 12 months.
From day 1 to 12 months.
Disease control rate (DCR)
Time Frame: From day 1 to 12 months.
From day 1 to 12 months.
Duration of response (DOR)
Time Frame: From day 1 to 12 months.
From day 1 to 12 months.
Overall survival (OS)
Time Frame: From day 1 to 12 months.
From day 1 to 12 months.
Response rate (RR)
Time Frame: From day 1 to 12 months.
From day 1 to 12 months.
Adverse events (AEs)
Time Frame: From day 1 to 40 days after the last dose.
From day 1 to 40 days after the last dose.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-A1811-315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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