NCT05896020

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for phase_2

Timeline
2mo left

Started Jul 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2023Jun 2026

First Submitted

Initial submission to the registry

May 28, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 10, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

2.9 years

First QC Date

May 28, 2023

Last Update Submit

August 21, 2023

Conditions

Gynaecological Malignancies

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    12 months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Treatment group with SHR-A1811

EXPERIMENTAL
Drug: SHR- A1811

Interventions

SHR- A1811DRUG

Subjects with gynaecological malignancies

Treatment group with SHR-A1811

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Central Study Contacts

Bo Li, Ph.D.

CONTACT

+86 021-61053363bo.li@hengrui.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm study of SHR-A1811
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2023

First Posted

June 9, 2023

Study Start

July 10, 2023

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2026

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations

CN(1)