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

ConditionOvarian Cancer

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexFemale

Age18+

SponsorHansoh BioMedical R&D Company

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation and written informed consent.

18 years and older, female.

Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Patients must have platinum-resistant disease

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

HS-20089
Drug
HS-20089 dose 1
Paclitaxel
Drug
Paclitaxel dose 2
Doxorubicin
Drug
Doxorubicin dose 3
Topotecan
Drug
Topotecan dose 4

Treatment groups

468 Participants

are divided into 2 treatment groups

Group A: Treatment group 1: HS-20089Experimental treatment 1 intervention

Group B: Treatment group 2: Investigator's choice of chemotherapyActive comparator 3 interventions

Trial outcomes

Primary outcomes

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

Time frame