Phase 2 Colorectal Cancer Trial, Recruiting

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

Who might be able to join this trial:

• People who have been diagnosed with advanced cancer that has spread to other parts of the body, confirmed by a lab test on a tissue or cell sample.
• During the dose-finding stage, people with a solid tumour that either has a specific gene marker called MGMT promoter hypermethylation, or a type of cancer where the chemotherapy drug temozolomide is a recognised standard treatment (such as neuroendocrine tumour, small cell lung cancer, melanoma, or soft tissue sarcoma) — and where a biopsy of the tumour can be safely performed.
• During the dose-finding stage, people with MGMT promoter hypermethylated colorectal cancer must have a specific tumour characteristic called mismatch repair proficient/microsatellite stable (confirm with trial site).
• During the later phase 2 stage, only people with mismatch repair proficient/microsatellite stable colorectal cancer that has the MGMT promoter hypermethylation marker, confirmed through testing of stored tissue samples.
• During the dose-finding stage, people whose cancer has progressed after trying all available treatments (including immunotherapy) known to help, or who cannot tolerate standard treatment, or who have chosen not to have standard treatment — and who have never previously received temozolomide or a type of drug called an ATR inhibitor.
• During phase 2, people with metastatic colorectal cancer who have already received at least one prior treatment regimen that included the chemotherapy drugs 5-fluorouracil, irinotecan, and oxaliplatin (with some flexibility around prior allergic reactions to oxaliplatin or use of these drugs in an earlier adjuvant setting, confirm with trial site).
• People aged 18 or older.
• People whose cancer can be measured on a CT scan and/or MRI scan according to standard measurement criteria (RECIST v1.1).
• People who are reasonably physically functional, rated at a standard level of 2 or below on a common performance scale (or 60% or above on an alternative scale).
• People with blood counts and organ function within acceptable ranges, including adequate levels of haemoglobin, white blood cells, neutrophils, and platelets, as well as acceptable liver and kidney function results (confirm specific values with trial site).
• People living with HIV who are on effective HIV treatment and have had an undetectable viral load within the past 6 months.
• People with chronic hepatitis B virus infection whose viral load is undetectable while on appropriate treatment.
• People who have previously had hepatitis C virus infection and have been successfully treated and cured, or who are currently on hepatitis C treatment with an undetectable viral load.
• People who have had cancer spread to the brain that has already been treated, provided that follow-up brain scans show no signs of the brain cancer growing for at least 4 weeks after that treatment.
• People who have or have had another separate cancer, as long as that cancer or its treatment is not expected to interfere with this trial's safety or results assessment.
• People with a history of heart disease or prior treatment with drugs that can affect the heart, provided their heart function is assessed as class 2B or better on a standard heart function scale.
• Women of childbearing potential who agree to use reliable contraception (hormonal, barrier method, or abstinence) before joining, throughout the trial, and for 6 months after the last dose of the study drug — and who agree to inform their treating doctor immediately if they become pregnant or suspect pregnancy during the trial.
• Men taking part who agree to use reliable contraception before joining, throughout the trial, and for 3 months after the last dose of the study drug.
• People who are able to understand the trial and are willing to sign a written consent form.

Who may not be able to join:

• People who have not recovered from side effects of previous cancer treatments, where those side effects are still rated above a mild level — with some exceptions allowed for hair loss and nerve-related symptoms at a moderate level.
• People who have had a serious allergic reaction to drugs chemically similar to the study drug M1774 or to temozolomide, including a drug called dacarbazine.
• People with other illnesses or health conditions that are not currently under control.
• People who are pregnant, as the study drugs may harm an unborn baby; and people who are breastfeeding, as the potential risk to a nursing infant is unknown.
• People who have a personal history of a rare genetic condition called ataxia telangiectasia.
• People who are unable to swallow tablets or capsules, or who have digestive conditions that may prevent the study medication from being properly absorbed.
• People who are unable to stop taking proton-pump inhibitor medications (a type of medication commonly used for heartburn or stomach acid, such as omeprazole) while on the study drug M1774.
• People who require radiation therapy covering more than 30% of the bone marrow during the trial.
• People with a specific heart electrical measurement (QTcF interval) greater than 480 milliseconds on a heart tracing (ECG), due to potential heart rhythm concerns.

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