Phase 1 Colorectal Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older at the time of signing the consent form.
• People with a laboratory-confirmed diagnosis of colorectal cancer (CRC) that cannot be surgically removed and has spread locally or to other parts of the body — or, depending on the trial phase, people with other types of advanced solid tumour cancers (such as triple-negative breast cancer, liver cancer, head and neck cancer, small cell lung cancer, ovarian cancer, stomach cancer, pancreatic cancer, or melanoma) where the tumour tests positive for a protein called B7-H6.
• People whose cancer has continued to grow despite all standard treatments, or who were unable to tolerate standard treatments, or for whom no standard treatment exists (this applies to certain parts of the trial — confirm with trial site which applies).
• People with tumours other than CRC must agree to provide a tumour sample so a central laboratory can confirm B7-H6 protein levels.
• People who have at least one tumour that can be measured or assessed using standard imaging criteria (known as RECIST v1.1), and — in certain phases of the trial — that tumour must not have been treated with radiation (or must show regrowth after radiation).
• People with a general health performance score of 0, 1, or 2 on a standard scale used by doctors (called ECOG Performance Status), meaning daily activities are not severely limited.
• People with a life expectancy of at least 3 months.
• People with adequate organ function and blood test results, as assessed by the trial team.
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting treatment.
• Women who could become pregnant, or men whose partner could become pregnant, must agree to use effective contraception from the time of signing the consent form, throughout the study, and for 6 months after the last dose of the study drug (TGI-6).

Who may not be able to join:

• People with known active tumours or cancer spread in the brain or central nervous system.
• People with a history of serious ongoing or active infections.
• People with a history of active autoimmune disease.
• People with a history of symptomatic interstitial lung disease (a type of lung inflammation or scarring).
• People whose side effects from previous cancer treatments have not settled back to mild or baseline levels, with some exceptions (such as hair loss, certain nerve-related side effects at a moderate level, or hormone-related side effects that are well managed with replacement therapy).
• People with severe or uncontrolled heart or blood vessel conditions that require treatment.
• People who have previously had a bone marrow transplant (either from a donor or their own cells) or any other organ transplant.
• People who have or have had another active cancer that has been progressing or required treatment within the past 3 years.
• People with significant suppression of the immune system.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires repeated draining procedures.
• People who have previously received any treatment that targets the B7-H6 protein.
• People who have received chemotherapy, targeted therapy, immunotherapy, or other anti-cancer treatments within 28 days (or within 5 half-lives of the drug, whichever is shorter) before starting the study drug — specific timeframes apply to certain drug types, so the trial site should be consulted for details.
• People who have received radiation therapy within 4 weeks before starting the study drug (a single session of palliative radiation may be an exception — confirm with trial site).
• People who have taken part in another clinical trial and received an experimental treatment within 28 days before starting TGI-6.
• People who have received certain immune-modifying drugs (such as thymosin, IL-2, or interferon) within 14 days before starting the study drug.
• People who have received a live vaccine within 4 weeks before starting the study drug.
• People who have had major surgery within 4 weeks before starting the study drug, or who are expected to need major surgery during the trial.
• People who require blood-thinning (anticoagulant) medication that cannot be safely paused if a study procedure such as a biopsy is needed, in the opinion of the treating doctor.
• People with a known psychiatric condition or substance use disorder that could affect their ability to follow the study requirements.
• Women who are pregnant or breastfeeding.
• People with a known allergy or sensitivity to TGI-6 or any of its ingredients.
• People with other serious medical conditions that, in the opinion of the trial doctor, could interfere with treatment, assessments, or follow-up, or that could put them at higher risk of complications.
• People who are unwilling or unable to follow the study procedures and requirements, or who the trial doctor considers unsuitable for the trial.

Important: Always verify eligibility with the trial site directly before applying.