A Study of SHR-A1811 in Subjects With Gynaecologic Oncology
NCT ID: NCT05896020
Last Updated: 2023-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
225 participants
INTERVENTIONAL
2023-07-10
2026-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group with SHR-A1811
SHR- A1811
Subjects with gynaecological malignancies
Interventions
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SHR- A1811
Subjects with gynaecological malignancies
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
FEMALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Qilu Hospital of Shandong University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR-A1811-209
Identifier Type: -
Identifier Source: org_study_id
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