Study on the Safety and Effectiveness of IMC-F106C Alone and with Other Cancer Treatments

Sponsor: Immunocore Ltd

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04262466

Provider View

This clinical trial is testing a new drug, IMC-F106C, designed to treat cancers that have a specific marker called PRAME. The study aims to find out if the drug is safe and effective for adults with certain types of cancer.

Patient Parameters

Program Overview

IMC-F106C is a new type of treatment that helps the immune system target cancer cells with a marker called PRAME. This study is the first time IMC-F106C is being tested in humans. It will look at how safe and effective the drug is for adults who have a specific tissue marker (HLA-A2) and whose cancer is positive for PRAME.

Description

The study is divided into two parts:

  1. Phase 1: This part will determine the safest dose of IMC-F106C when used alone or with other cancer treatments like chemotherapy and targeted therapies. Researchers will find the highest dose that patients can tolerate without severe side effects.

  2. Phase 2: This part will evaluate how well IMC-F106C works in treating certain advanced solid tumors. Researchers will assess the drug's effectiveness in shrinking tumors or stopping their growth.

Eligibility Criteria

Inclusion Criteria

  • Must be in good general health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have a specific genetic marker called HLA-A*02:01.
  • Cancer must be positive for the PRAME marker.
  • Cancer must have returned, not responded to, or not tolerated standard treatments, or be used in combination with standard treatments.
  • If applicable, must agree to use highly effective birth control methods.

Exclusion Criteria

  • Have untreated or symptomatic cancer spread to the brain.
  • Have had a recent bowel blockage.
  • Have ongoing fluid buildup in the abdomen or chest that needs frequent drainage.
  • Have had significant immune-related side effects from previous immunotherapy.
  • Have not had enough time since the last cancer treatment to safely start the study drug.
  • Have ongoing side effects from previous cancer treatments.
  • Have abnormal lab test results.
  • Have significant lung, heart, or autoimmune diseases.
  • Need ongoing treatment that suppresses the immune system.
  • Have had a solid organ or bone marrow transplant.
  • Have active infections like hepatitis B, hepatitis C, or HIV.
  • Have another significant cancer.
  • Have allergies to the study drug or its ingredients.
  • Have had antibiotics, vaccines, or surgery within 2-4 weeks before starting the study.
  • Are pregnant or breastfeeding.
  • Have any other condition that would prevent safe participation in the study.

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