Phase 1 Stomach 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 (or aged 16 or older for one specific group involving a rare cancer called ASPS) who are willing and able to follow the study schedule and procedures
• People with a general health status rated as fully active or able to carry out light work (ECOG performance status 0 or 1) before starting treatment
• People whose liver, blood, and kidney function meet specific minimum levels as measured by blood tests (confirm details with trial site)
• People with a life expectancy of at least 90 days
• Cohorts A-1 and A-2 (Japanese patients only): People of Japanese background with any type of solid tumour that has continued to grow or spread after standard treatments, or who could not tolerate standard treatment
• Cohort B-1: People with confirmed pancreatic ductal adenocarcinoma (a type of pancreatic cancer) whose cancer has progressed after, or who could not tolerate, one prior chemotherapy treatment for advanced or spread disease
• Cohort B-2: People with confirmed colorectal cancer (bowel cancer) whose cancer progressed after, or who could not tolerate, one standard chemotherapy treatment for advanced or spread disease
• Cohort B-3: People with confirmed non-squamous non-small cell lung cancer (NSCLC) whose cancer has progressed after one or two standard chemotherapy treatments, and whose most recent treatment included both an immunotherapy drug (a checkpoint inhibitor) and platinum-based chemotherapy — and who had a confirmed response followed by confirmed disease progression on that treatment
• Cohort C-1: People with confirmed advanced or returning stomach cancer or cancer at the junction of the stomach and oesophagus that cannot be surgically removed, and who have received two to four specific standard treatments and experienced disease progression on the most recent one
• Cohort C-2: People with confirmed advanced bowel cancer (colon or rectum, adenocarcinoma type only) whose RAS gene status has been tested, and who have received at least two prior chemotherapy regimens including specific required drugs based on their RAS status, with confirmed disease progression or intolerance to the last treatment
• Cohort D-1: People with confirmed advanced or metastatic NSCLC (any type) whose tumour tests show high PD-L1 expression (50% or more) and who have received no prior treatment for advanced disease (confirm with trial site)
• Cohort D-2: People with confirmed advanced or metastatic oesophageal cancer (adenocarcinoma or squamous cell type) who have not previously received treatment for advanced or metastatic disease
• Cohort D-3: People with confirmed advanced or metastatic oesophageal cancer (adenocarcinoma or squamous cell type) who have either had no prior treatment for advanced disease, or whose cancer did not respond to or could not tolerate at least one cycle of standard first-line treatment
• Cohorts D-4 and D-5: People with confirmed advanced or returning squamous head and neck cancer (affecting the mid-throat, mouth lining, lower throat, or voice box) whose HPV status has been tested, and who have not previously received treatment for advanced or metastatic disease (confirm eligibility details with trial site)
• Cohort D-6: People with confirmed advanced or metastatic squamous NSCLC who have not previously received treatment for advanced or metastatic disease
• Cohort D-7: People with confirmed advanced or inoperable bile duct or gallbladder cancer (adenocarcinoma or adenosquamous type) who have not previously received treatment for advanced or metastatic disease
• Cohort D-8: People with confirmed advanced or inoperable pancreatic ductal adenocarcinoma who have not previously received treatment for advanced or metastatic disease
• Cohort E-1: People with confirmed advanced or metastatic NSCLC (any type) whose tumour shows high PD-L1 expression (50% or more, except in a tolerability sub-group), who have received one to four prior treatment regimens including at least one immunotherapy (checkpoint inhibitor) treatment, with confirmed disease progression during or after that immunotherapy
• Cohort E-2: People with confirmed advanced or metastatic alveolar soft part sarcoma (ASPS), aged 16 or older

Who may not be able to join:

• People with a history of or current heart rhythm problems, or other conditions that increase the risk of a specific type of heart electrical abnormality (QT prolongation), such as heart failure or a genetic heart condition
• People who have had major surgery within the past 4 weeks, wide-area radiation therapy within the past 4 weeks, limited-area radiation therapy within the past 2 weeks, any anti-cancer treatment within the past 2 weeks, or another experimental drug within 4 weeks or 5 half-lives of that drug (whichever is shorter)
• People who still have significant side effects (Grade 2 or higher) from previous cancer treatments, not including anaemia, certain nerve tingling/numbness, hair loss, or skin colour changes
• People with a known active serious infection anywhere in the body
• People with a known history of or currently active scarring/inflammation of the lungs (interstitial lung disease, drug-induced lung disease, or radiation pneumonitis) that required steroid treatment
• People who have had a heart attack, severe unstable chest pain, or significant heart failure within the past 6 months (those with these conditions more than 6 months ago may be considered if heart function is normal and they have no cardiac symptoms — confirm with trial site)
• People with known severe chronic kidney disease
• People who test positive for HIV, hepatitis B surface antigen, or hepatitis C antibody (although people who test positive for hepatitis C antibody but negative for active hepatitis C virus may still be considered — confirm with trial site)
• People with another separate active cancer, unless it is a very early-stage or previously cured cancer of specific types (such as early cervical changes, treated skin cancer, or any cancer fully treated more than 5 years ago — confirm with trial site)
• Women who are able to become pregnant, or men whose partners could become pregnant, who do not agree to use effective contraception during the study and for a specified period after the last dose of study drugs
• People who have previously been treated with certain immunotherapy drugs (checkpoint inhibitors such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies), except in certain specific cohorts where prior immunotherapy is part of the eligibility criteria
• People who have received a live vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, or BCG) within the 30 days before starting study treatment
• People with a known immune system deficiency, or who are currently taking high-dose steroid medication (more than 10 mg of prednisone or equivalent per day) or other immune-suppressing drugs within 7 days before enrolment
• People with an active autoimmune disease that has required systemic medical treatment within the past 2 years (standard hormone or gland replacement therapy is generally not considered a disqualifying treatment — confirm with trial site)
• People with active cancer that has spread to the brain or the lining of the brain (carcinomatous meningitis); people with previously treated brain metastases may be considered if the disease has been stable for at least 28 days and no steroids have been needed for at least 14 days (confirm with trial site)
• People with other serious medical or psychiatric conditions, or other circumstances, that in the treating doctor's judgement would make participation unsafe or unsuitable — including but not limited to bowel obstruction, respiratory failure, kidney or liver failure, stroke-related conditions, active bleeding stomach ulcers, wounds or fractures with abnormal blood vessel growth, or fluid build-up around the lungs, abdomen, or heart requiring drainage within 2 weeks before enrolment

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