RecruitingPhase 2NCT06155396

A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent or Metastatic Cervical Cancer

A Single-Arm, Open- Label, Multicenter Phase II Study of RC48-ADC in Combination With Zimberelimab Injection for the Treatment ,at Least First-line Platinum-containing Standard Therapy Failed in HER2-expressing Subject With Recurrent or Metastatic Cervical Cancer


Sponsor

RemeGen Co., Ltd.

Enrollment

116 participants

Start Date

Jan 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the efficacy,safety of RC48-ADC in Combination with Zimberelimab Injection for the Treatment ,at least first-line platinum-containing standard therapy failed in HER2-expressing subject with Recurrent or Metastatic Cervical Cancer


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — RC48-ADC (a targeted antibody-drug) and zimberelimab (an immunotherapy) — in women with cervical cancer that has come back or spread, and has stopped responding to standard platinum-based chemotherapy. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with recurrent or metastatic cervical cancer confirmed by biopsy - Your cancer has the HER2 protein (any level of expression) - You have tried at least one prior standard chemotherapy treatment containing platinum and it did not work - You are not a suitable candidate for surgery or radiation - Your expected survival is at least 12 weeks - Your general health and organ function meet study requirements **You may NOT be eligible if...** - You have not yet tried standard chemotherapy - You are still able to receive surgery or radiation - Your cancer does not express the HER2 protein - Your organ function or overall health does not meet the required thresholds 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

DRUGDisitamab Vedotin

2.0 mg/kg IV every 2 weeks

DRUGZimberelimab

240mg IV every 2 weeks


Locations(12)

The first affiliated hospital of bengbu medical college

Bengbu, Anhui, China

Beijing Obstetrics and Gynecology Hospital ,Capital Medical University

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Guangxi Tumor Hospital

Nanning, Guangxi, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Shandong Cancer Hospital & Institute

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06155396


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