SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

August 8, 2024 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

A Randomized, Open-Label, Controlled, Phase III Study of SHR-A1921 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

440

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 Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:
          • Lingyin Wu, Doctor
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Tao Zhu, Doctor

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. Voluntary participation and written informed consent.
  2. 18 years and older, female.
  3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
  4. Patients must have platinum-resistant disease
  5. Be able to provide fresh or archived tumour tissue.
  6. At least one measurable lesion according to RECIST v1.1.
  7. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
  8. With a life expectancy ≥ 12 weeks.
  9. Adequate bone marrow reserve and organ function.
  10. Contraception is required during the trial.

Exclusion Criteria:

  1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
  2. Previous or co-existing malignancies.
  3. Current or History of ILD.
  4. Clinical symptoms or diseases of the heart that are not well controlled.
  5. Arterial/venous thrombosis events occurred before the first dose.
  6. Grade ≥2 bleeding events of CTCAE occurred before the first dose.
  7. Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose.
  8. Patients with intestinal obstruction or parenteral nutrition before the first dose.
  9. Serious infection before the first dose.
  10. Active hepatitis B or active hepatitis C.
  11. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
  12. Treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
  13. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
  14. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921.
  15. Other inappropriate situation considered by the investigator.

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: Treatment group 1: SHR-A1921
Drug: SHR-A1921
SHR-A1921 dose 1
Active Comparator: Treatment group 2: Investigator's choice of chemotherapy
Drug: Doxorubicin
Doxorubicin dose 2
Drug: Paclitaxel
Paclitaxel dose 3
Drug: Topotecan
Topotecan dose 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year
Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year
Duration of Response (DoR), assessed by site investigator as per RECIST 1.1
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year
Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year
Response Rate (RR) assessed by RECIST 1.1 and Gynaecologic Cancer Intergroup (GCIG) criteria
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year
CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year
Adverse Events
Time Frame: Screening up to study completion, an average of 1 year
Screening up to study completion, an average of 1 year

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)

May 10, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 27, 2024

First Submitted That Met QC Criteria

April 27, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-A1921-303

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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