Ovarian Cancer
Conditions
Brief summary
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
Interventions
DRUGTopotecan
Topotecan dose 4
DRUGSHR-A1921
SHR-A1921 dose 1
DRUGDoxorubicin
Doxorubicin dose 2
DRUGPaclitaxel
Paclitaxel dose 3
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
To evaluate the efficacy and safety of SHR-A1921 compared with investigator-chosen chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
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 tumour 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. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms. 2. Previous or co-existing malignancies. 3. Current or History of ILD. 4. Clinical symptoms or diseases of the heart that are not well controlled. 5. Arterial/venous thrombosis events occurred before the first dose. 6. Grade ≥2 bleeding events of CTCAE occurred before the first dose. 7. Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose. 8. Patients with intestinal obstruction or parenteral nutrition before the first dose. 9. Serious infection before the first dose. 10. Active hepatitis B or active hepatitis C. 11. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment. 12. Treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload. 13. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy. 14. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921. 15. 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 |
| CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria | Screening up to study completion, an average of 1 year |
| Adverse Events | Screening up to study completion, an average of 1 year |
| Response Rate (RR) assessed by RECIST 1.1 and Gynaecologic Cancer Intergroup (GCIG) criteria | Screening up to study completion, an average of 1 year |
Countries
China
Contacts
Primary ContactShuni Wang
Backup ContactDi Zong
Outcome results
None listed