Ovarian Cancer
Conditions
Keywords
Platinum-resistant recurrent epithelial ovarian cancer, HS-20089, randomized, phase III
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.
Interventions
DRUGHS-20089
HS-20089 dose 1
DRUGPaclitaxel
Paclitaxel dose 2
DRUGDoxorubicin
Doxorubicin dose 3
DRUGTopotecan
Topotecan dose 4
Sponsors
Hansoh BioMedical R&D Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Overall Survival (OS) | 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 |
| Objective Response Rate (ORR), assessed by BIRC as per RECIST 1.1 | Screening up to study completion, an average of 1 year |
Countries
China
Contacts
Primary ContactLingying Wu, MD
Outcome results
None listed