Study on the Safety and Effectiveness of IMC-F106C Alone and with Other Cancer Treatments
Sponsor: Immunocore Ltd
ClinicalTrials ID:NCT04262466
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
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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:
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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.
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California - San Diego | 92093 | La Jolla | California |
| Angeles Clinic and Research Institute | 90025 | Los Angeles | California |
| University of California Davis Comprehensive Center | 95817 | Sacramento | California |
| University of Colorado | 80045 | Aurora | Colorado |
| Georgetown University Medical Center | 20057 | Washington | District of Columbia |
| Houston Lee Moffitt Cancer Center & Research Institute | 33612 | Tampa | Florida |
| The University of Chicago Medical Center | 60637 | Chicago | Illinois |
| University of Iowa | 52242 | Iowa City | Iowa |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| John Theurer Cancer Center at Hackensack University Medical Center | 07601 | Hackensack | New Jersey |
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