A Study of SHR-A1811 in Subjects With Ovarian Cancer | NCT06828354

Studies
A Study of SHR-A1811 in Subjects With Ovarian Cancer

NCT06828354

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Status

Recruiting

Last Update Posted

Apr 20, 2026Actual

Enrollment

300Estimated

Phase

Phase 3

Conditions

Ovarian Cancer

Interventions

SHR-A1811
Paclitaxel Injection
Doxorubicin Hydrochloride Liposome Injection
Gemcitabine Hydrochloride for Injection
Topotecan Hydrochloride for Injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 13, 2025Actual

Primary Completion Date

May 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Feb 10, 2025

First Submission Date that Met QC Criteria

Feb 10, 2025

First Posted Date

Feb 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2026

Last Update Posted Date

Apr 20, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SHR-A1811 group	Experimental		Drug: SHR-A1811
Chemotherapy group	Active Comparator		Drug: Paclitaxel Injection Drug: Doxorubicin Hydrochloride Liposome Injection Drug: Gemcitabine Hydrochloride for Injection Drug: Topotecan Hydrochloride for Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SHR-A1811	Drug	SHR-A1811.	SHR-A1811 group
Paclitaxel Injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression free survival (PFS)		From day 1 to 10 months.

Secondary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)		From day 1 to 12 months.
Disease control rate (DCR)		From day 1 to 12 months.
Duration of response (DOR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subjects voluntarily joined the study and signed the Informed consent forms (ICF).
Measurable disease, as defined by RECIST v1.1.
The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
Life expectancy ≥ 12 weeks.

Exclusion Criteria:

Symptomatic, untreated or active central nervous system metastases.
Have uncontrolled or severe cardiovascular disease.
With any active autoimmune disease or history of autoimmune disease.
Patients with active hepatitis B or hepatitis C.
Severe infections prior to initiation of study treatment.
Patients with active tuberculosis.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuanchao Wang	Contact	0518-82342973		yuanchao.wang@hengrui.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology	Recruiting	Wuhan	Hubei	430030	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017239	Paclitaxel
D000093542	Gemcitabine
D007267	Injections
D019772	Topotecan

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided