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A Study of SHR-A1811 in Subjects With Gynaecologic Oncology

RECRUITINGPhase 2Sponsored by Jiangsu HengRui Medicine Co., Ltd.
Actively Recruiting
PhasePhase 2
SponsorJiangsu HengRui Medicine Co., Ltd.
Started2023-07-10
Est. completion2026-06-15
Eligibility
Age18 Years – 75 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05896020

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.

Eligibility

Age: 18 Years – 75 YearsSex: FEMALEHealthy volunteers accepted
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.

Conditions2

CancerGynaecological Malignancies

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