RecruitingPhase 2Phase 3NCT06221748

DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy

A Randomized,Multicenter, Open-Label,Phase II/III Study to Evaluate the Safety and Efficacy of Disitamab Vedotin Combined With Cadonilimab in Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma Who Have Progressed on r First-line Therapy


Sponsor

RemeGen Co., Ltd.

Enrollment

90 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — an antibody-drug conjugate (DV) and an immunotherapy drug (Cadonilimab) — in people with advanced stomach or gastroesophageal junction cancer that has stopped responding to first-line treatment and has a protein called HER2 on the tumor. **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced or metastatic stomach or gastroesophageal junction cancer confirmed by biopsy - Your cancer has the HER2 protein present (even at low levels) - Your cancer stopped working or you could not tolerate your first standard treatment - Your heart, liver, kidneys, and blood counts are functioning adequately - You are willing to use contraception during and for 6 months after treatment **You may NOT be eligible if...** - Your cancer has spread to the brain or the lining of the brain - You have previously received an antibody-drug conjugate treatment - You have had a major infection, heart attack, stroke, or blood clot in the past 6 months - You are pregnant or breastfeeding - You have active hepatitis B, C, or HIV - You have an autoimmune disease requiring ongoing systemic treatment 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 Injection

Phase II and III study :2.5mg/kg, intravenous infusion,D1, every 2 weeks

DRUGCadonilimab Injection

Phase II and III study :6.0mg/kg, intravenous infusion,D1, every 2 weeks.

DRUGPaclitaxel Injection

Phase II and III study :Calculate dosage based on body surface are,160mg/m2,intravenous infusion,D1,D8 every 3 weeks


Locations(12)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Shandong Cancer Hospital

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06221748


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