A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer

September 24, 2025 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

An Open, Multicenter Phase Ib / II Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer

The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the effectiveness of SHR-A1811 combined regimen in the treatment of platinum sensitive recurrent epithelial ovarian cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2
  • Phase 1

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, 430000
        • Recruiting
        • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Qinglei Gao
        • 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. Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with the follow-up.
  2. Sufficient fresh or archived tumor tissue specimens can be provided for testing by the third-party central laboratory designated by the sponsor.
  3. At least one measurable lesion conforming to RECIST v1.1.
  4. ECOG PS score: 0-1.
  5. Expected survival ≥ 12 weeks.
  6. Female subjects with fertility must agree to comply with the contraceptive requirements from signing the informed consent form to 7 months after the last administration of the trial drug.

Exclusion Criteria:

  1. With untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis.
  2. Pleural effusion, pericardial effusion or peritoneal effusion with clinical symptoms, which cannot be well controlled.
  3. Previous interstitial pneumonia or interstitial lung disease, non infectious pneumonia requiring steroid treatment.
  4. With hypertension and cannot be well controlled by antihypertensive drug treatment.
  5. Accompanied by poorly controlled or serious cardiovascular diseases.
  6. Subjects with serious infection within 1 month before the first medication.
  7. Have a history of immune deficiency, including HIV test positive, other acquired or congenital immune deficiency diseases, or a history of organ transplantation.
  8. There are any other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, criminal detention, and other serious diseases (including mental illness) that need combined treatment.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Drug: SHR-A1811
SHR-A1811.
Drug: Carboplatin
Carboplatin.
Drug: Bevacizumab
Bevacizumab.
Drug: Adebrelimab Injection
Adebrelimab injection.
Drug: Oxaliplatin for Injection
Oxaliplatin for injection.
Drug: Paclitaxel injection
Paclitaxel injection.
Drug: Doxorubicin hydrochloride liposome injection
Doxorubicin hydrochloride liposome injetction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose limited toxicity (DLT)
Time Frame: Up to 21 days.
Up to 21 days.
Recommended phase II dose (RP2D)
Time Frame: Up to 21 days.
Up to 21 days.
Objective response rate (ORR)
Time Frame: Every 9 weeks lasting about one year.
Every 9 weeks lasting about one year.

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of response (DoR)
Time Frame: Every 9 weeks lasting about one year.
Every 9 weeks lasting about one year.
Disease control rate (DCR)
Time Frame: Every 9 weeks lasting about one year.
Every 9 weeks lasting about one year.
Progression free survival (PFS)
Time Frame: Every 9 weeks lasting about one year.
Every 9 weeks lasting about one year.
Standard response rate (RR)
Time Frame: Every 9 weeks lasting about one year.
Every 9 weeks lasting about one year.
Overall survival (OS)
Time Frame: Approximately 3 years after the last subject enrolled.
Approximately 3 years after the last subject enrolled.
Adverse events (AEs)
Time Frame: From the first drug administration to within 90 days after the last dose.
From the first drug administration to within 90 days after the last dose.
Serious adverse events (SAEs)
Time Frame: From the first drug administration to within 90 days after the last dose.
From the first drug administration to within 90 days after the last dose.

Collaborators and Investigators

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

Sponsor

Suzhou Suncadia Biopharmaceuticals 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 18, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

February 21, 2025

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-A1811-216-OC

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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