Study on EMB-01 for Patients with Advanced Gastrointestinal Cancers

Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05176665

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, EMB-01, in treating advanced gastrointestinal cancers, such as stomach, liver, bile duct, and colorectal cancers, especially in patients whose cancer has specific genetic changes and who have no other treatment options.

Patient Parameters

Program Overview

The study aims to evaluate how safe and effective EMB-01 is for patients with advanced gastrointestinal cancers, including stomach, liver, bile duct, and colorectal cancers. It focuses on patients whose cancers have specific genetic changes related to EGFR and cMET and who have not benefited from standard treatments. The study includes several stages: a molecular pre-screening to check for genetic changes, a clinical screening to confirm eligibility, a treatment phase, and follow-up periods to monitor safety and disease progression.

Description

This clinical trial is an open-label study, meaning both the researchers and participants know what treatment is being given. It is divided into two parts: Phase Ib and Phase II. The study involves patients with advanced gastrointestinal cancers, such as stomach, liver, bile duct, and colorectal cancers, who have specific genetic changes in the EGFR or cMET genes. These patients have already tried standard treatments without success or have no other treatment options available.

Before joining the study, patients will undergo a molecular pre-screening to check for specific genetic changes in their cancer. Only those who meet these criteria will proceed to the clinical screening to determine if they are eligible to participate. The study includes a treatment period where patients receive EMB-01, followed by safety and disease progression follow-up periods to monitor their response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have specific genetic changes in the cMET or EGFR genes in their cancer.
  • Have advanced stomach, liver, bile duct, or colorectal cancer that has not responded to standard treatments or for which no standard treatments are available.
  • Have measurable cancer that can be tracked using standard criteria.
  • Provide a tumor sample for genetic testing.
  • Have good organ function as determined by medical tests.
  • Have stopped any previous cancer treatments for a specified period before starting EMB-01.
  • Use effective birth control during the study and for three months after treatment if they or their partner can become pregnant.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Do not agree to the genetic pre-screening.
  • Have genetic changes that make them resistant to EGFR or cMET inhibitors.
  • Have a life expectancy of less than three months.
  • Have cancer that has spread to the brain and is causing symptoms.
  • Are pregnant or breastfeeding.
  • Have had major surgery within the last 28 days and have not fully healed.
  • Have serious medical conditions that could interfere with the study or increase the risk of complications.

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