A Study of SHR-A1811 in Subjects With Gynaecologic Oncology

Phase 2

Recruiting

• Conditions: Gynaecological Malignancies
• Interventions: Drug: SHR- A1811

• Registration Number: NCT05896020
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-28
• Study First Submitted QC: 2023-06-08
• Study First Posted: 2023-06-09
• Study Start: 2023-07-10
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-22
• Primary Completion: 2026-06-15
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 225

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group with SHR-A1811	SHR- A1811	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	12 months

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	12 months
Objective response rate (ORR)	12 months
Disease control rate (DCR)	12 months
Duration of response (DOR)	12 months
Overall survival (OS)	12 months
Incidence and severity of adverse events (AEs)	From Day 1 to 90 days after last dose

Trial Locations

Locations (1)

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