Ovarian Cancer
Conditions
Brief summary
This is an open-label, randomized, controlled, two-part study to evaluate the safety and efficacy of SHR-A1921 with or without carboplatin verus investigator's choice of platinum-based doublet chemotherapy in subjects with recurrent epithelial ovarian cancer.
Interventions
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SHR-A1921 with or without Carboplatin compared with Investigator's Choice of Platinum-based Doublet Chemotherapy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntary participation and written informed consent. 2. Be able to provide fresh or archived tumour tissue. 3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. 4. At least one measurable lesion according to RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) score: 0-1. 6. With a life expectancy ≥ 12 weeks. 7. Adequate bone marrow reserve and organ function.
Exclusion criteria
1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms. 2. Previous or co-existing malignancies. 3. Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis; 4. Subjects with active hepatitis B or active hepatitis C; 5. Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment. 6. Subjects who have been treated with TOP1 inhibitors, TROP-2 ADC or ADCs with TOP1 inhibitors as payload. 7. Has unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate Assessed by Investigator According to RECIST v1.1 | Screening up to study completion, an average of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| CA-125 Response assessed by the Gynecologic Cancer Intergroup (GCIG) criteria | Screening up to study completion, an average of 1 year |
| Duration of Response (DoR) Assessed by Investigator as per RECIST 1.1 | Screening up to study completion, an average of 1 year |
| Disease Control Rate (DCR) Assessed by Investigator as per RECIST 1.1 | Screening up to study completion, an average of 1 year |
| Progression-Free Survival (PFS) Assessed by 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 |
Contacts
Primary ContactYuanchao Wang
Outcome results
None listed