Study on MRG004A for Patients with Advanced or Metastatic Solid Tumors with Tissue Factor

Sponsor: Shanghai Miracogen Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04843709

Provider View

This clinical trial is testing a new drug, MRG004A, to see if it is safe and effective for patients with advanced or metastatic solid tumors that have a specific marker called Tissue Factor. The study will also look at how the body processes the drug and its potential immune reactions.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of MRG004A in patients with advanced or metastatic solid tumors that test positive for Tissue Factor. It will also examine how the drug is processed in the body and any immune responses it might trigger.

Description

The study is divided into two parts. Part A will determine the safest and most effective dose of MRG004A by gradually increasing the dose given to patients. Part B will focus on specific types of cancer to further assess how well the drug works and its safety at the dose determined in Part A.

Participants will receive MRG004A and undergo regular health checks to monitor their response to the treatment and any side effects. The study will help researchers understand the potential benefits and risks of MRG004A for treating advanced cancers with Tissue Factor.

Eligibility Criteria

Inclusion Criteria

  • Must understand and agree to the study requirements and provide written consent.
  • Age 18 years or older.
  • Expected to live at least 6 more months.
  • For Part B, must have a tumor that tests positive for Tissue Factor.
  • Must have cancer that cannot be removed by surgery or has spread, and has worsened after previous treatments.
  • For Part B, must have no other treatment options that improve survival and joining a clinical trial is a reasonable option.
  • Must have measurable cancer according to specific criteria.
  • Must be in good general health with a performance status of 0 or 1.
  • Must have acceptable bone marrow, liver, heart, kidney, and blood clotting function.
  • Women aged 18-55 must have a negative pregnancy test.
  • Must agree to use effective birth control during and for 180 days after the last dose of MRG004A.

Exclusion Criteria

  • Tumor does not show positive Tissue Factor expression for Part B patients.
  • Side effects from previous cancer treatments are not resolved to a mild level.
  • Have untreated or unstable brain metastases.
  • Have received other cancer treatments within 21 days before starting the study.
  • Have a high risk of bleeding.
  • Have severe heart problems.
  • Have had a blood clot in the lungs or deep veins within 3 months before starting the study.
  • Have another active cancer within the last 5 years.
  • Have uncontrolled high blood pressure.
  • Have a history of certain heart rhythm problems.
  • Have difficulty breathing at rest.
  • Have had major surgery within 4 weeks or minor surgery within 2 weeks before starting the study.
  • Have allergies to MRG004A or similar drugs.
  • Have liver disease, serious infections, or autoimmune diseases.
  • Have active infections.
  • Have used certain medications like steroids or strong enzyme inhibitors recently.
  • Are pregnant or breastfeeding.
  • Have any severe or uncontrolled health conditions that make participation unsafe.

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