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

Phase 3

Not yet recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: Paclitaxel; Drug: HS-20089; Drug: Doxorubicin; Drug: Topotecan

• Registration Number: NCT06855069
• Lead Sponsor: Hansoh BioMedical R&D Company

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-25
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Study Start: 2025-03-07
• Primary Completion: 2027-03-07
• Study Completion: 2029-03-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 468

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group 2: Investigator's choice of chemotherapy	Paclitaxel	-
Treatment group 2: Investigator's choice of chemotherapy	Doxorubicin	-
Treatment group 2: Investigator's choice of chemotherapy	Topotecan	-
Treatment group 1: HS-20089	HS-20089	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Duration of Response (DoR), assessed by BIRC as per RECIST 1.1	Screening up to study completion, an average of 1 year
Disease Control Rate (DCR), assessed by BIRC as per RECIST 1.1	Screening up to study completion, an average of 1 year
Adverse Events	Screening up to study completion, an average of 1 year

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China