Ovarian Cancer
Conditions
Brief summary
This is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.
Interventions
DRUGSHR-A1811
SHR-A1811.
DRUGPaclitaxel Injection
Paclitaxel Injection.
Doxorubicin Hydrochloride Liposome Injection.
DRUGGemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for Injection.
Topotecan Hydrochloride for Injection.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The subjects voluntarily joined the study and signed the Informed consent forms (ICF). 2. Measurable disease, as defined by RECIST v1.1. 3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1. 4. Life expectancy ≥ 12 weeks.
Exclusion criteria
1. Symptomatic, untreated or active central nervous system metastases. 2. Have uncontrolled or severe cardiovascular disease. 3. With any active autoimmune disease or history of autoimmune disease. 4. Patients with active hepatitis B or hepatitis C. 5. Severe infections prior to initiation of study treatment. 6. Patients with active tuberculosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | From day 1 to 10 months. |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR) | From day 1 to 12 months. |
| Duration of response (DOR) | From day 1 to 12 months. |
| Objective response rate (ORR) | From day 1 to 12 months. |
| Response rate (RR) | From day 1 to 12 months. |
| Adverse events (AEs) | From day 1 to 40 days after the last dose. |
| Overall survival (OS) | From day 1 to 12 months. |
Countries
China
Contacts
Primary ContactYuanchao Wang
Outcome results
None listed