Gynaecological Malignancies
Conditions
Brief summary
This is an open-label, two-part study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with a gynaecological malignancies.
Interventions
DRUGSHR- A1811
Subjects with gynaecological malignancies
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm study of SHR-A1811
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 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. 5. Subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer.
Exclusion criteria
1. Symptomatic, untreated or active central nervous system metastases. 2. Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc.. 3. Have uncontrolled or severe cardiovascular disease. 4. With any active autoimmune disease or history of autoimmune disease. 5. Patients with active hepatitis B or hepatitis C. 6. Severe infections within 28 days prior to initiation of study treatment. 7. Active tuberculosis within one year prior to initiation of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DOR) | 12 months |
| Overall survival (OS) | 12 months |
| Disease control rate (DCR) | 12 months |
| Progression free survival (PFS) | 12 months |
| Objective response rate (ORR) | 12 months |
| Incidence and severity of adverse events (AEs) | From Day 1 to 90 days after last dose |
Countries
China
Contacts
Primary ContactBo Li, Ph.D.
Outcome results
None listed