A Study of SHR-A1811 in Subjects With Ovarian Cancer

Phase 3

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: Paclitaxel Injection; Drug: SHR-A1811; Drug: Doxorubicin Hydrochloride Liposome Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Topotecan Hydrochloride for Injection

• Registration Number: NCT06828354
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-14
• Status Verified: 2025-03
• Study Start: 2025-03-13
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2027-05
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy group	Paclitaxel Injection	-
Chemotherapy group	Doxorubicin Hydrochloride Liposome Injection	-
Chemotherapy group	Gemcitabine Hydrochloride for Injection	-
Chemotherapy group	Topotecan Hydrochloride for Injection	-
SHR-A1811 group	SHR-A1811	-

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	From day 1 to 10 months.

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	From day 1 to 12 months.
Disease control rate (DCR)	From day 1 to 12 months.
Duration of response (DOR)	From day 1 to 12 months.
Overall survival (OS)	From day 1 to 12 months.
Response rate (RR)	From day 1 to 12 months.
Adverse events (AEs)	From day 1 to 40 days after the last dose.

Trial Locations

Locations (2)

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China