A Study of SHR-A1811 in Subjects With Gynaecologic Oncology
ConditionGynaecological Malignancies
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
The subjects voluntarily joined the study and signed the ICF.
Measurable disease, as defined by RECIST v1.1.
The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
Life expectancy ≥ 12 weeks.
Disqualifiers
Symptomatic, untreated or active central nervous system metastases.
Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc..
Have uncontrolled or severe cardiovascular disease.
With any active autoimmune disease or history of autoimmune disease.
Trial design
Treatments tested in this trial
- SHR- A1811
Treatment groups
225 Participants
are divided into 1 treatment groupLocations
1Qilu Hospital of Shandong University250012, JinanShandong, China
Sponsors and collaborators
Jiangsu HengRui Medicine Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov