RecruitingPhase 1Phase 2NCT06572319

Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC/GEJ Patiens

Phase I/II Clinical Study of the Combination of Disitamab Vedotin and Trastuzumab in the Treatment of HER2 Positive Gastric/Gastroesophageal Junction Tumors With Previous Systemic Therapy Failure


Sponsor

Zhejiang Cancer Hospital

Enrollment

35 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a single center, single arm, open label clinical study aimed at evaluating the efficacy and safety of the combination therapy of Disitamab Vedotin and trastuzumab in the treatment of advanced HER-2 positive gastric/gastroesophageal junction tumors


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two targeted drugs — disitamab vedotin and trastuzumab — for people with stomach or gastroesophageal junction cancer that is HER2-positive (a specific protein found on the surface of some cancer cells) and has spread or cannot be surgically removed. **You may be eligible if...** - You are 18 to 74 years old - Your cancer has been confirmed as HER2-positive stomach or gastroesophageal junction adenocarcinoma - Your cancer has spread or returned and cannot be removed with surgery - You have at least one measurable tumor - Your performance status is good (ECOG 0–1) - You have already received at least one prior line of treatment that failed **You may NOT be eligible if...** - Your cancer is not HER2-positive - You have never received prior systemic therapy for metastatic disease - You have serious organ problems or other active cancers - You are pregnant or breastfeeding 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(RC48) Plus Tratuzumab

Disitamab Vedotin: 2.5mg/kg,ivgtt,D1, every 2 weeks for a treatment cycle. Tratuzumab: RP2D,ivgtt,D1, every 2 weeks for a treatment cycle.


Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06572319


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