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

Last updated: August 8, 2024
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Ovarian Cancer

Ovarian Cysts

Pelvic Cancer

Treatment

Topotecan

Doxorubicin

Paclitaxel

Clinical Study ID

NCT06394492
SHR-A1921-303
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntary participation and written informed consent.

  2. 18 years and older, female.

  3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, orfallopian 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

Exclusion Criteria:

  1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion withclinical 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 abscessoccurred 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 studytreatment.

  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 orinactive ingredients of SHR-A1921.

  15. Other inappropriate situation considered by the investigator.

Study Design

Total Participants: 440
Treatment Group(s): 4
Primary Treatment: Topotecan
Phase: 3
Study Start date:
May 10, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Active - Recruiting

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