RecruitingPhase 1Phase 2NCT06859775

SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer

Open-label, Multicenter Phase Ib/II Clinical Study of Injectable SHR-A1811 in Combination Regimens for the Treatment of Recurrent or Metastatic Cervical Cancer


Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

100 participants

Start Date

Apr 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a multicentre, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of SHR-A1811 combination regimen in the treatment of recurrent or metastatic cervical cancer and to preliminarily evaluate the efficacy of SHR-A1811 combination regimen for recurrent or metastatic cervical cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug combination that includes SHR-A1811 (an antibody-drug conjugate targeting HER2) for women with recurrent or metastatic cervical cancer that has come back or spread after prior treatment. **You may be eligible if...** - You are a woman aged 18–75 with recurrent or metastatic cervical cancer - Your vital organ function (heart, liver, kidneys) is adequate - You have a life expectancy of at least 12 weeks - You have a negative pregnancy test and agree to use contraception during and after treatment **You may NOT be eligible if...** - You have a current or prior other cancer diagnosis - You have severe bone damage from bone metastases - You have active autoimmune disease - You have active tuberculosis - You have poorly controlled heart disease or blood clots in the past 6 months - You have had a bowel obstruction recently or in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-A1811

SHR-A1811 injection.

DRUGAdebelimab injection

Adebelimab injection.

DRUGBevacizumab injection

Bevacizumab injection.

DRUGSHR-8068

SHR-8068 injection.

DRUGCisplatin injection

Cisplatin injection.

DRUGCarboplatin injection

Carboplatin injection.


Locations(1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT06859775


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