Study on EMB-01 and Osimertinib for Patients with EGFR Mutant Lung Cancer

Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05498389

Provider View

This clinical trial is testing a new treatment combining EMB-01 and osimertinib to see if it is safe and effective for patients with advanced non-small cell lung cancer (NSCLC) that has a specific EGFR mutation and has spread to other parts of the body.

Patient Parameters

Program Overview

The purpose of this study is to find out if the combination of EMB-01 and osimertinib can help stop the growth of cancer cells in patients with advanced non-small cell lung cancer (NSCLC) that has a specific mutation in the EGFR gene. The study will also determine the best dose of EMB-01 to use with osimertinib and evaluate how well this combination works in treating the cancer.

Description

The study is divided into two phases. In Phase Ib, researchers will determine the safest and most effective dose of EMB-01 when used with osimertinib. In Phase II, they will assess how well this combination works in shrinking tumors in patients whose cancer has progressed after previous treatments.

Participants will receive EMB-01 through an IV once a week and take osimertinib pills daily. Each treatment cycle lasts 28 days, and the treatment can continue for up to two years unless the cancer worsens or side effects become too severe.

The study will also look at how the body processes these drugs, how the immune system responds to them, and how effective they are in controlling the cancer. After finishing the treatment, participants will have follow-up visits to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have advanced or metastatic non-small cell lung cancer (NSCLC) with a specific EGFR mutation.
  • Have cancer that can be measured or evaluated using standard criteria.
  • Be willing to provide a blood sample for genetic testing.
  • Provide a tumor sample for analysis before starting the study treatment.
  • Have previously received standard treatment and have no other available therapies.
  • Meet specific criteria based on previous treatments and genetic mutations, such as having progressed on osimertinib or other EGFR-targeted therapies.

Exclusion Criteria

  • Have a life expectancy of less than 3 months.
  • Have severe side effects from previous cancer treatments, except for certain conditions like hair loss or mild fatigue.
  • Have cancer that has spread to the brain and is causing symptoms, unless treated and stable.
  • Have significant heart problems, such as recent heart attacks, uncontrolled high blood pressure, or heart failure.
  • Have a history of immune system disorders, organ transplants, or tuberculosis.

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