A Study of SHR-A1811 in Subjects With Gynaecologic Oncology

• Status: Not yet recruiting
• Trial end date: 2026-06-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.