A Study of SHR-A1811 in Subjects With Gynaecologic Oncology | NCT05896020

Studies
A Study of SHR-A1811 in Subjects With Gynaecologic Oncology

NCT05896020

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Status

Unknown status

Last Update Posted

Aug 22, 2023Actual

Enrollment

225Estimated

Phase

Phase 2

Conditions

Gynaecological Malignancies

Interventions

SHR- A1811

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

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2023Actual

Primary Completion Date

Jun 15, 2026Estimated

Completion Date

Jun 15, 2026Estimated

First Submitted Date

May 28, 2023

First Submission Date that Met QC Criteria

Jun 8, 2023

First Posted Date

Jun 9, 2023Actual

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

Aug 21, 2023

Last Update Posted Date

Aug 22, 2023Actual

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, two-part study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with a gynaecological malignancies.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

225Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group with SHR-A1811	Experimental		Drug: SHR- A1811

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SHR- A1811	Drug	Subjects with gynaecological malignancies	Treatment group with SHR-A1811

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)		12 months

Secondary Outcomes

Measure	Description	Time Frame
Progression free survival (PFS)		12 months
Objective response rate (ORR)		12 months
Disease control rate (DCR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subjects voluntarily joined the study and signed the 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.
Subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer.

Exclusion Criteria:

Symptomatic, untreated or active central nervous system metastases.
Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc..
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 within 28 days prior to initiation of study treatment.
Active tuberculosis within one year prior to initiation of study treatment.

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
Bo Li, Ph.D.	Contact	+86 021-61053363		bo.li@hengrui.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qilu Hospital of Shandong University	Recruiting	Jinan	Shandong	250012	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