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Trial Title:
A Study of SHR-A1811 in Subjects With Gynaecologic Oncology
NCT ID:
NCT05896020
Condition:
Gynaecological Malignancies
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single arm study of SHR-A1811
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR- A1811
Description:
Subjects with gynaecological malignancies
Arm group label:
Treatment group with SHR-A1811
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Beihua Kong, Doctor
Phone:
+86-18653199168
Email:
kongbeihua@sdu.edu.cn
Start date:
July 10, 2023
Completion date:
June 15, 2026
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05896020
