To hear about similar clinical trials, please enter your email below
Trial Title:
SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer
NCT ID:
NCT06394492
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Paclitaxel
Doxorubicin
Topotecan
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1921
Description:
SHR-A1921 dose 1
Arm group label:
Treatment group 1: SHR-A1921
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
Doxorubicin dose 2
Arm group label:
Treatment group 2: Investigator's choice of chemotherapy
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Paclitaxel dose 3
Arm group label:
Treatment group 2: Investigator's choice of chemotherapy
Intervention type:
Drug
Intervention name:
Topotecan
Description:
Topotecan dose 4
Arm group label:
Treatment group 2: Investigator's choice of chemotherapy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Lingyin Wu, Doctor
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Zhu, Doctor
Start date:
May 10, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06394492
