Actively Recruiting

Phase 2
Age: 18Years - 75Years
FEMALE
NCT05896020

A Study of SHR-A1811 in Subjects With Gynaecologic Oncology

Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2023-08-22

225

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Study of SHR-A1811 in Subjects With Gynaecologic Oncology

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • The subjects voluntarily joined the study and signed the informed consent form.
  • Measurable disease as defined by RECIST v1.1.
  • Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
  • Life expectancy of at least 12 weeks.
  • Subjects with advanced cervical cancer, recurrent ovarian cancer, or endometrial cancer.
Not Eligible

You will not qualify if you...

  • Symptomatic, untreated, or active central nervous system metastases.
  • Previous treatment with antibody-drug conjugates containing topoisomerase I inhibitors such as Enhertu (DS-8201a) or U3-1402.
  • Uncontrolled or severe cardiovascular disease.
  • Active autoimmune disease or history of autoimmune disease.
  • Active hepatitis B or hepatitis C infection.
  • Severe infections within 28 days before starting study treatment.
  • Active tuberculosis within one year before starting study treatment.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250012

Actively Recruiting

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Research Team

B

Bo Li, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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