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

December 15, 2025 updated by: Hansoh BioMedical R&D Company

A Multi-center, Randomized, Open-label, Controlled, Phase III Clinical Study Evaluating HS-20089 vs. Investigator's Choice of Chemotherapy in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

468

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
      • Beijing, China
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences

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 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 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 requiring clinical intervention.
  4. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
  5. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
  6. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of HS-20089.
  7. Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with the study participation or study drug administration.
  8. 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
Active Comparator: Treatment group 2: Investigator's choice of chemotherapy
Drug: Topotecan
Topotecan dose 4
Drug: Paclitaxel
Paclitaxel dose 2
Drug: Doxorubicin
Doxorubicin dose 3
Experimental: Treatment group 1: HS-20089
Drug: HS-20089
HS-20089 dose 1

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
Adverse Events
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 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
Duration of Response (DoR), assessed by 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
Disease Control Rate (DCR), assessed by 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

Collaborators and Investigators

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

Sponsor

Hansoh BioMedical R&D Company

Investigators

  • Principal Investigator: Lingying Wu, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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)

March 7, 2027

Study Completion (Estimated)

March 7, 2029

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-20089-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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