Phase 2 Head and Neck 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
• People whose doctor estimates they have a life expectancy of at least 12 weeks
• People whose cancer can be measured on scans, according to standard medical criteria (RECIST v1.1)
• People who are fully active or have only minor limitations in daily activity (this is measured using a standard scale called ECOG, scores 0 or 1)
• People who are able to swallow capsules
• For the Phase 1b and 2a parts of the trial: people with an advanced solid tumour that cannot be surgically removed, and for which standard treatments no longer work, are not tolerated, or do not exist. If previously treated with a type of immunotherapy called an anti-PD-1/PD-L1 drug, the cancer must have clearly progressed while on that treatment, with progression confirmed within 16 weeks of the last dose, after receiving at least 2 doses
• For the head and neck cancer (HNSCC) group in Phase 2a: people with metastatic or unresectable, recurrent head and neck squamous cell carcinoma whose tumour tests positive for a protein called PD-L1 (CPS score of 1 or higher), and who have not previously received anti-PD-1/PD-L1 immunotherapy — or people with recurrent or metastatic HNSCC whose cancer has progressed during or after platinum-based chemotherapy
• For the bile duct cancer (BTC) group in Phase 2a: people with locally advanced, unresectable, or metastatic biliary tract cancer who have already received, or were unable to tolerate, standard first-line chemotherapy and second-line targeted therapy (where applicable)
• For the bowel cancer (CRC) group in Phase 2a: people with a specific subtype of colorectal cancer (pMMR/MSS) who have not previously received anti-PD-1/PD-L1 immunotherapy, and whose cancer has progressed after at least 2 prior lines of standard chemotherapy (with targeted biological agents where applicable). Note: people with liver metastases from bowel cancer are not eligible for this group (confirm with trial site)
• People with adequate blood counts, including: white blood cells, platelets, and haemoglobin at required levels (without a red blood cell transfusion in the past 2 weeks), and normal blood clotting levels
• People with adequate liver and kidney function, within specified ranges for blood test results
• People who are able to understand and follow all study requirements; for Phase 2a, people willing to provide a stored tumour sample or have a new biopsy taken during screening
• People with a normal heart electrical reading (QTcF interval of 470 milliseconds or less on an ECG)
• People with normal heart pumping function (ejection fraction within their institution's normal range)
• People who have stopped other cancer treatments — at least 5 half-lives before starting the study drug for non-biological treatments, or at least 4 weeks for biological treatments
• People whose side effects from previous treatments have mostly resolved (to a low level, Grade 1 or less), except for hair loss or mild nerve-related symptoms; people with mild hormone-related side effects requiring ongoing treatment or hormone replacement may still be considered
• People who finished radiotherapy at least 14 days before starting the study treatment, with side effects mostly resolved and no ongoing need for steroid medicines
• Women who are not pregnant and not breastfeeding, and who either cannot become pregnant (due to menopause of at least 1 year, or surgical sterilisation), or who have a negative pregnancy test within 3 days of starting treatment and agree to use effective contraception during the study and for at least 30 days after the last dose of TU2218, or at least 120 days after the last dose of pembrolizumab, whichever is later

Who may not be able to join:

• People who have had a heart attack within the past 6 months, or who have fluid around the heart (pericardial effusion)
• People who have had heart or aortic surgery within the past 12 months
• People with unstable chest pain, stroke, mini-stroke, serious blood clots in the lungs or legs, or blocked arteries within the past 12 months
• People with severe heart failure (New York Heart Association Class III or IV)
• People with significant heart rhythm problems identified by ECG, as judged by the study doctor
• People with uncontrolled high blood pressure (systolic 160 mmHg or higher, or diastolic 100 mmHg or higher) at the time of screening
• People with significantly elevated levels of a heart damage marker called Troponin I (Grade 3) at screening
• People with cancer that has spread to the brain or the lining of the brain, or with large uncontrolled fluid build-up in the chest, abdomen, or around the heart, or cancer spread through the lung's lymphatic system
• People with a known history of difficulty swallowing, poor nutrient absorption, or other conditions that may reduce how well the study drug is absorbed
• People with a tumour pressing on or growing into major blood vessels, or a tumour with cavities that the study doctor believes is at risk of bleeding
• People with a history of severe bleeding, or who cannot stop blood-thinning or anti-clotting medications throughout the study and for at least 28 days after the last dose
• People with moderate or severe heart valve problems, including valve narrowing or leakage
• People with a known or suspected aneurysm (bulging of a blood vessel) in the heart or major blood vessels
• Women who are pregnant or at risk of becoming pregnant without using highly effective contraception; male participants must also use contraception (condom with spermicide) or abstain from sexual activity from the time of giving consent until at least 30 days after the last dose of TU2218 or 120 days after the last dose of pembrolizumab, whichever is later
• Women who are currently breastfeeding
• For Phase 1b and the BTC group in Phase 2a: people who previously had to stop immunotherapy (anti-PD-1, anti-PD-L1, anti-PD-L2, or similar drugs targeting immune checkpoints) due to an immune-related side effect
• For the CRC and HNSCC groups in Phase 2a: people who have previously received immunotherapy targeting PD-1, PD-L1, PD-L2, or related immune checkpoint pathways
• People who received systemic cancer treatment (including experimental drugs) within 4 weeks before starting the study (a shorter interval may apply for some drugs — confirm with trial site); people must have recovered from previous treatment side effects to a low level before joining
• People who received radiotherapy within 2 weeks of starting the study, or who have a history of radiation-related lung inflammation; a 1-week gap may be permitted for short-course palliative radiotherapy to areas outside the brain (confirm with trial site)
• People who have received, or are planned to receive, a live or live-attenuated vaccine (such as for measles, mumps, rubella, or chickenpox) within 30 days before the first study drug dose or during the study; mRNA vaccines (including COVID-19 vaccines) are not permitted within 7 days before the first dose or during the first 2 treatment cycles
• People currently taking part in, or who have taken part in, another clinical trial using an experimental drug or device within 4 weeks before the first study dose (those in the follow-up phase of another trial may be considered if it has been at least 4 weeks since their last dose)
• People who have had an organ or tissue transplant from another person
• People who have previously received treatment targeting a biological pathway called TGF-Beta
• People with a known immune system deficiency, or who are currently taking high-dose steroid medicines (more than 10 mg of prednisone daily or equivalent), or other immune-suppressing medicines within 7 days before the first dose
• People with another active or recently treated cancer (within the past 3 years), except for certain skin cancers or carcinoma in situ that have been treated with curative intent
• People with a known severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients
• People with an active autoimmune disease, or a history of autoimmune disease that has required systemic treatment within the past 2 years (except for conditions such as vitiligo, an underactive thyroid, or childhood asthma/allergies that have resolved); hormone replacement therapy for other conditions is generally permitted
• People with a history of lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition
• People with an active infection currently requiring antibiotic treatment
• People with a known active or significant bacterial, fungal, or viral infection, including known hepatitis B, hepatitis C, or HIV
• For Phase 1b dose escalation: people unable or unwilling to stop taking certain medications that affect how the study drug is processed by the body (strong inhibitors of CYP1A2, CYP2C8, CYP3A4, P-gP, or BCRP) at least 8 days before and during treatment
• For Phase 1b dose escalation: people unable or unwilling to stop taking medicines that reduce stomach acid (such as proton pump inhibitors, H2 blockers, or antacids) at least 8 days before and during treatment
• People with any medical condition, ongoing therapy, or abnormal test result that the study doctor believes would make participation unsafe or interfere with the study results
• People with a known psychiatric condition or substance use disorder that would make it difficult to follow study requirements
• People with a known or suspected allergy to any ingredient in the study treatments
• People with any other serious medical condition that the study doctor believes would make participation unsafe

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