A Study of SHR-A1811 in Subjects With Ovarian Cancer

NCT06828354 · tracked via the Priya Life Science China tracker

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Phase

Phase 3

Started

2025-03-13

Last updated

2026-04-20

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

SHR-A1811Paclitaxel InjectionDoxorubicin Hydrochloride Liposome InjectionGemcitabine Hydrochloride for InjectionTopotecan Hydrochloride for Injection

SHR-A1811: SHR-A1811.

Paclitaxel Injection: Paclitaxel Injection.

Doxorubicin Hydrochloride Liposome Injection: Doxorubicin Hydrochloride Liposome Injection.

Gemcitabine Hydrochloride for Injection: Gemcitabine Hydrochloride for Injection.

Topotecan Hydrochloride for Injection: Topotecan Hydrochloride for Injection.

Study summary

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

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

Progression free survival (PFS) — From day 1 to 10 months.

Trial sites (2)

Facility	City	Region	Status
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	Recruiting
Qilu Hospital of Shandong University	Jinan	Shandong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06828354 on ClinicalTrials.gov ↗ ← All trials in China