HS-20089 injection for platinum-resistant recurrent epithelial ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label phase III trial compares HS-20089 injections to investigator-selected chemotherapy (paclitaxel, doxorubicin, or topotecan) in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Eligible adult women must have pathologically confirmed disease, measurable lesions by RECIST v1.1, ECOG 0–1, adequate organ function, and be able to provide fresh or archived tumor tissue. Patients are excluded if they received prior TOP1 inhibitors or TOP1-payload ADCs, have recent systemic anticancer therapy within 4 weeks, unresolved grade ≥2 toxicities, or uncontrolled effusions requiring intervention. The trial will monitor efficacy and safety endpoints to determine whether HS-20089 offers improved outcomes over standard chemotherapy choices.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Lingying Wu, MD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Lingying Wu, MD
• Email: wulingying@csco.org.cn
• Phone: (+86)13910865483

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.