Study on EMB-01 Dose Escalation and Expansion for Adults with Advanced or Metastatic Solid Tumors

Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03797391

Provider View

This clinical trial is testing a new drug, EMB-01, to see if it is safe and effective for treating adults with advanced or metastatic solid tumors that have not responded to standard treatments or have no available standard treatments.

Patient Parameters

Program Overview

This study is the first time EMB-01, a new drug targeting specific cancer markers, is being tested in humans. It is open to adults with advanced solid tumors that have either not responded to existing treatments or have no standard treatment options. The study has two parts: Phase I, which will determine the safest dose, and Phase II, which will explore the drug's effectiveness in specific types of cancer. Participants will be grouped based on their cancer's genetic characteristics. The study includes a pre-screening phase, a clinical screening phase, treatment cycles lasting up to two years, and a follow-up period to monitor safety.

Description

This clinical trial is exploring a new treatment called EMB-01, which is designed to target specific proteins found in certain advanced cancers. The study is divided into two phases. Phase I will focus on finding the safest dose of EMB-01 by gradually increasing the dose given to participants. Phase II will expand the study to include more participants and will focus on how well the drug works in treating specific types of cancer, particularly those with certain genetic mutations.

Participants will be grouped based on their cancer's genetic profile, and the study will include a pre-screening phase to determine eligibility. The treatment involves cycles that last 28 days each, and participants can continue treatment for up to two years. After completing the treatment, there will be a follow-up period to ensure the drug's safety.

The study aims to recruit a total of 33-66 participants in Phase I and 42-120 participants in Phase II. Participants will undergo various tests and evaluations throughout the study to monitor their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Must agree to a pre-screening process to check for specific genetic markers in their cancer (Phase II only).
  • Must be willing to sign an informed consent form.
  • Have a confirmed diagnosis of advanced or metastatic solid tumors, such as lung, colorectal, gastric, or liver cancer, that have not responded to standard treatments or have no available standard treatments.
  • For Phase II, must have specific genetic mutations in their cancer and have tried standard treatments, including platinum-based therapy, without success.
  • Must have adequate organ function as determined by medical tests.
  • Must have stopped previous cancer treatments for a specified period before starting the study.
  • Women who can become pregnant and men with partners who can become pregnant must use effective birth control during the study and for three months after.
  • Must have a performance status score indicating they are fully active or have some restrictions but can still perform light work.

Exclusion Criteria

  • Not willing to participate in the pre-screening process (Phase II only).
  • Do not meet the genetic criteria for the study (Phase II only).
  • Have a life expectancy of less than three months.
  • Have cancer that has spread to the brain or spinal cord and is causing symptoms.
  • Are pregnant or breastfeeding.
  • Have had major surgery within the last 28 days.
  • Have serious medical conditions that could interfere with the study, such as uncontrolled high blood pressure, heart disease, diabetes, or active infections.

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