HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

Last updated: February 25, 2025
Sponsor: Hansoh BioMedical R&D Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Ovarian Cancer

Ovarian Cysts

Vaginal Cancer

Treatment

Doxorubicin

HS-20089

Topotecan

Clinical Study ID

NCT06855069
HS-20089-301
  • Ages > 18
  • Female

Study Summary

This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of HS-20089 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 tumor 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. Prior treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.

  2. Previous or co-existing malignancies.

  3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiringclinical intervention.

  4. Received systemic anticancer treatments 4 weeks prior to the initiation of the studytreatment.

  5. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.

  6. History of severe hypersensitivity reactions to either the drug substances orinactive ingredients of HS-20089.

  7. Any serious or uncontrolled medical disorder in the opinion of the investigator thatmay increase the risk associated with the study participation or study drugadministration.

  8. Other inappropriate situation considered by the investigator.

Study Design

Total Participants: 468
Treatment Group(s): 4
Primary Treatment: Doxorubicin
Phase: 3
Study Start date:
March 07, 2025
Estimated Completion Date:
March 07, 2029

Connect with a study center

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing,
    China

    Site Not Available

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