RecruitingPhase 2NCT04868162

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

An Open-Label, Single Arm, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck.


Sponsor

Shanghai Miracogen Inc.

Enrollment

116 participants

Start Date

Apr 23, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 and the combination of MRG003 and HX008 in patients with recurrent or metastatic squamous cell carcinoma of head and neck.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests MRG003, a new targeted drug called an antibody-drug conjugate, in patients with squamous cell carcinoma of the head and neck that has come back or spread and cannot be surgically removed. The drug is designed to deliver chemotherapy directly to cancer cells while sparing healthy tissue. **You may be eligible if...** - You have confirmed squamous cell cancer of the head and neck that has returned or spread - You have already tried platinum-based chemotherapy and/or an immunotherapy drug (anti-PD-1) that didn't work - You are in generally good health (ECOG score 0 or 1) - You have at least one measurable tumor on scans - You are willing to use effective contraception during and for 6 months after treatment **You may NOT be eligible if...** - You have had 4 or more prior systemic cancer treatments - You have significant nerve damage (grade 2 or higher peripheral neuropathy) - You have previously been treated with a similar type of targeted drug (MMAE/MMAF antibody-drug conjugate) - You have a very low BMI (17 or under) - You have active brain metastases, HIV, active hepatitis B or C, or an uncontrolled autoimmune disease - 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

DRUGMRG003

On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg or 2.3 mg/kg.

DRUGMRG003+HX008

On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg or the recommended dose by SMC; and HX008 will be administered via intravenous infusion at 3.0 mg/kg


Locations(1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

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NCT04868162


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