A Study of SHR-A1811 in Subjects With Ovarian Cancer

Phase 3RecruitingNCT06828354

Jiangsu HengRui Medicine Co., Ltd.300 enrolled

Overview

This is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Ovarian Cancer

Interventions

SHR-A1811DRUG

SHR-A1811.

Paclitaxel InjectionDRUG

Paclitaxel Injection.

Doxorubicin Hydrochloride Liposome InjectionDRUG

Doxorubicin Hydrochloride Liposome Injection.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The subjects voluntarily joined the study and signed the Informed consent forms (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. Exclusion Criteria: 1. Symptomatic, untreated or active central nervous system metastases. 2. Have uncontrolled or severe cardiovascular disease. 3. With any active autoimmune disease or history of autoimmune disease. 4. Patients with active hepatitis B or hepatitis C. 5. Severe infections prior to initiation of study treatment. 6. Patients with active tuberculosis.

Locations (2)

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

Progression free survival (PFS)

Time frame: From day 1 to 10 months.