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

NCT06855069 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: HS-20089-301
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Keywords

Platinum-resistant recurrent epithelial ovarian cancer; HS-20089; randomized; phase III

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1

  Screening up to study completion, an average of 1 year

Secondary Outcomes (8)

• Overall Survival (OS)

  Screening up to study completion, an average of 1 year

• Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1

  Screening up to study completion, an average of 1 year

• Duration of Response (DoR), assessed by site investigator as per RECIST 1.1

  Screening up to study completion, an average of 1 year

• Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1

  Screening up to study completion, an average of 1 year

• Objective Response Rate (ORR), assessed by BIRC as per RECIST 1.1

  Screening up to study completion, an average of 1 year

Study Arms (2)

Treatment group 1: HS-20089

EXPERIMENTAL

Drug: HS-20089

Treatment group 2: Investigator's choice of chemotherapy

ACTIVE COMPARATOR

Drug: Paclitaxel; Drug: Doxorubicin; Drug: Topotecan

Interventions

HS-20089 DRUG

HS-20089 dose 1

Treatment group 1: HS-20089

Paclitaxel DRUG

Paclitaxel dose 2

Treatment group 2: Investigator's choice of chemotherapy

Doxorubicin DRUG

Doxorubicin dose 3

Treatment group 2: Investigator's choice of chemotherapy

Topotecan DRUG

Topotecan dose 4

Treatment group 2: Investigator's choice of chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prior treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
• Previous or co-existing malignancies.
• Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.
• Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
• Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
• History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of HS-20089.
• 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.
• Other inappropriate situation considered by the investigator.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Paclitaxel; Doxorubicin; Topotecan

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Lingying Wu, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingying Wu, MD

CONTACT

(+86)13910865483; wulingying@csco.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: March 13, 2025
• Primary Completion (Estimated): March 7, 2027
• Study Completion (Estimated): March 7, 2029
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

CN (1)