A Study of SHR-A1811 in Subjects With Gynaecologic Oncology

Hengrui Medicine

Status and phase: Enrolling; Phase 2

Conditions: Gynaecological Malignancies

Treatments: Drug: SHR- A1811

Study type: Interventional

Funder types: Industry

Identifiers

NCT05896020

SHR-A1811-209

Details and patient eligibility

About

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.

Enrollment: 225 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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225 participants in 1 patient group

Treatment group with SHR-A1811

Experimental group

Treatment:

Drug: SHR- A1811