Study on MRG002 for Patients with HER2-Positive Advanced Solid Tumors and Advanced Gastric or Gastroesophageal Cancer

Sponsor: Shanghai Miracogen Inc.

Sponsor score: 0

ClinicalTrials ID:NCT04492488

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, MRG002, in patients with advanced HER2-positive cancers, including gastric and gastroesophageal cancers. The study also examines how the body processes the drug and its potential to trigger an immune response.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety, effectiveness, and how the body processes MRG002 in patients with advanced HER2-positive cancers, including those affecting the stomach and gastroesophageal junction. Researchers will also check if the drug causes any immune reactions.

Description

The study is divided into two parts. In Part A, patients will receive MRG002 alone at doses of 2.2 or 2.6 mg/kg through an IV drip over 60-90 minutes on the first day of every three-week cycle. This part aims to find the highest dose patients can tolerate and the best dose for future studies. In Part B, patients will receive a single IV dose of MRG002 at the recommended dose on the first day of every three-week cycle.

Eligibility Criteria

Inclusion Criteria

  • Must be able to provide written consent and follow study requirements.
  • Age 18 or older.
  • Expected to live at least 6 more months.
  • Must have confirmed HER2-positive cancer that has spread and cannot be removed by surgery, and must have tried all standard treatments.
  • Must provide a sample of tumor tissue.
  • Must have at least one measurable tumor that has not been treated with radiation.
  • Must be in good general health with an ECOG performance status of 0 or 1.
  • Must have acceptable liver, kidney, blood, and clotting function.

Exclusion Criteria

  • Side effects from previous cancer treatments must be mild (except hair loss and fatigue).
  • Side effects from radiation must be mild and resolved at least 21 days before screening.
  • Cannot have had radiation to target tumors that will be measured in the study.
  • Cannot have untreated or uncontrolled brain metastases.
  • Cannot have had any cancer treatments within 3 weeks of starting the study.
  • Cannot have severe heart problems within 6 months before joining the study.
  • Cannot have had blood clots in the lungs or deep veins within 3 months before starting the study.
  • Cannot have another active cancer within the last 5 years.
  • Cannot have uncontrolled high blood pressure.
  • Cannot have a history of certain heart rhythm problems.
  • Cannot have severe breathing problems or need continuous oxygen therapy.
  • Cannot have had major surgery within 4 weeks or minor surgery within 2 weeks before starting the study.
  • Cannot have allergies to MRG002 or similar drugs.
  • Cannot have certain liver diseases or uncontrolled infections.
  • Cannot have severe uncontrolled diseases or be using certain medications.
  • Cannot be pregnant or breastfeeding.

Locations

FACILITYZIPCITYSTATE
University of California Irvine Chao Family Comprehensive Cancer Center92868OrangeCalifornia
MD Anderson Cancer Center77040HoustonTexas

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