RecruitingPhase 2NCT05896020

A Study of SHR-A1811 in Subjects With Gynaecologic Oncology

Open, Multicenter Phase II Clinical Study of SHR-A1811 for Injection in the Treatment of Gynaecological Malignancies

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

225 participants

Start Date

Jul 10, 2023

Study Type

INTERVENTIONAL

Conditions

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.

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

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.
Subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer.

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.
Patients with active hepatitis B or hepatitis C.
Severe infections within 28 days prior to initiation of study treatment.
Active tuberculosis within one year prior to initiation of study treatment.

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DRUGSHR- A1811

Subjects with gynaecological malignancies

Qilu Hospital of Shandong University

Jinan, Shandong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT05896020