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:

• People who have a confirmed advanced or spreading cancer (proven by tissue or cell testing), where the specific cancer type and treatment history match the requirements for either the early-phase portion or one of the four specific cancer groups (sarcoma, non-small cell lung cancer, colorectal cancer, or stomach/gastro-esophageal junction cancer) — details differ by group, so confirm with the trial site.
• People whose cancer has not responded to, or has stopped responding to, standard treatments, or for whom standard treatments are no longer available, were refused, or were not tolerated (requirements vary by cancer group).
• People with an overall health and activity level rated as fully active or restricted only in physically strenuous activity (performance status 0 or 1 on a standard medical scale).
• People who have recovered from side effects of previous cancer treatments, with most effects either mild or stable for at least three months.
• People who have at least one tumour that can be safely biopsied, with a suitable tissue sample available (either recent archival tissue or a new sample, within timeframes that vary by phase — confirm with the trial site).
• People who have at least one tumour spot that can be measured using a standard imaging method (called RECIST 1.1).
• People who are able to swallow and keep down an oral (tablet or capsule) medication, without significant stomach or bowel problems that could affect how it is absorbed.
• People who are willing and able to follow all study requirements, including attendance at appointments and completing assessments.
• People whose blood, kidney, and liver function meet the minimum levels required by the study (assessed through standard blood tests).

Who may not be able to join:

• People who have received certain recent cancer treatments too close to the start of the study, including chemotherapy, immunotherapy, radiation, or targeted therapies (exact waiting periods differ by treatment type — confirm with the trial site), except for people in one specific stomach cancer group currently on a qualifying treatment.
• People who have brain metastases (cancer spread to the brain) that are growing, causing symptoms, or requiring steroid or immune-suppressing medications.
• People with an active infection (bacterial, viral, or fungal) currently requiring intravenous antibiotic or antiviral treatment.
• People with unstable chronic obstructive pulmonary disease (a serious lung condition with frequent or severe flare-ups), as assessed by the treating doctor.
• People with a known history of, or currently active, hepatitis B or hepatitis C infection.
• People with HIV where the virus is not well controlled, or where immune cell counts are too low, based on recent blood tests.
• People with known bleeding disorders, abnormal blood clotting results at screening, or a history of gastrointestinal bleeding (from inflammation, ulcers, or bowel pockets) within the past two years.
• People with a known H. pylori (stomach bacteria) infection that has not been confirmed as cleared at least two months before screening.
• People currently taking certain medications that change stomach acid levels (such as proton pump inhibitors within 7 days, or H2 blockers within 12 hours of the first study dose), unless adjustments are made based on a specific sub-study — confirm with the trial site.
• People who have taken steroid medications (above a low daily dose threshold) within 14 days before the first study dose.
• People who are planned to receive the combination therapy arm and have an active autoimmune disease that has required systemic treatment in the past two years (hormone replacement therapies for conditions like thyroid or adrenal insufficiency are generally not considered a reason for exclusion — confirm with trial site).
• People who have taken anti-inflammatory medications such as NSAIDs or COX-2 inhibitors (like ibuprofen or celecoxib) recently before starting the study, though low-dose aspirin at certain doses may be permitted — confirm with trial site.
• People who are taking strong medications that significantly affect how the liver processes certain drugs (CYP and UGT enzyme inhibitors or inducers) within 14 days before starting the study.
• People with a specific type of irregular heart rhythm reading (QTcF interval above 450 ms on an ECG).
• People with a known allergy to any ingredient in the study drug (OKN4395), or to pembrolizumab (for those in the combination treatment groups).
• People who are pregnant or breastfeeding; women who could become pregnant must have a negative pregnancy test at screening and before starting treatment.
• People who have had another active cancer requiring systemic treatment within the two years before screening (some exceptions apply for certain early-stage or skin cancers — confirm with trial site).
• People with any other medical condition, past surgery, or abnormal test result that the treating doctor believes could make participation unsafe, interfere with the study results, or make it difficult to monitor the person's health throughout the trial.

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