NCT05620134

Who might be able to join this trial:

• You must be 18 years of age or older.
• You must be willing to sign a consent form and be able to follow the study schedule and procedures.
• For the dose-finding part of the trial, you must have been diagnosed with one of these cancers that cannot be surgically removed, has spread locally, or has spread to other parts of the body: non-small cell lung cancer, small cell lung cancer, melanoma, certain types of kidney cancer, bladder cancer, head and neck cancer, certain types of breast cancer, stomach or esophageal junction cancer, esophageal squamous cell cancer, skin squamous cell cancer, pancreatic cancer, liver cancer (certain severity levels only), colorectal cancer, ovarian cancer, cervical cancer, uterine cancer, or certain types of thyroid cancer.
• For the expansion part of the trial, specific rules apply depending on your cancer type — for example, lung cancer patients must have had no more than 2 prior treatments; colorectal cancer patients must have cancer outside the liver and have tried at least 2 prior standard treatments; liver cancer patients must have had only one prior treatment including an immune therapy (confirm with trial site).
• You must be well enough to carry out light activity and care for yourself — your doctor will assess this using a standard scale (ECOG score of 0 or 1).
• You are expected to live for at least 12 weeks.
• Your cancer must be measurable on a CT or MRI scan.
• Your blood test results must meet certain minimum levels for protein, platelets, red blood cells, white blood cells, liver function, and kidney function (confirm specific values with trial site).
• A stored sample of your tumor tissue must be available (a tissue block or a set of around 10–15 slides).
• Some patients may be asked to agree to a fresh tumor biopsy before and during treatment.
• If you are a woman who could become pregnant, you must have a negative pregnancy test within 72 hours before starting the study drug, and must use 2 effective forms of contraception from screening through 90 days after your last dose.
• If you are a man whose partner could become pregnant, you must use effective barrier contraception or practice complete abstinence from the time of consent through 90 days after stopping the study drug, and your partner should also use contraception during this time.
• If you have had cancer spread to the brain, it must have been treated, you must have had no symptoms for at least 14 days, and you must not be on any active treatment for it at the time of joining.
• You must be willing and able to attend clinic visits as required by the study.
• You may continue using hormones for breast cancer or unrelated conditions (such as insulin or hormone replacement therapy), and bone-strengthening medications are also permitted.

Who may not be able to join:

• You have brain or spinal cord involvement from your cancer that is currently causing symptoms or is unstable.
• You have a serious autoimmune disease that the study doctor believes would put you at unacceptable risk.
• You have had major surgery within 6 weeks before starting treatment.
• You have had a significant heart or blood vessel problem in the past 6 months, such as a heart attack, dangerous irregular heartbeat, very high uncontrolled blood pressure, a blood clot in the lungs, heart failure, or certain other heart conditions.
• You have had serious gut problems such as a hole in the gut wall, significant gastrointestinal bleeding, pancreatitis, or you have a history of Crohn's disease or ulcerative colitis.
• You have significant breathing problems that require you to use supplemental oxygen.
• You had a severe (Grade 3 or higher) immune-related side effect from a previous cancer immunotherapy drug.
• You have received a live virus vaccine within 4 weeks before starting the study drug (standard flu shots are allowed; you must have had at least 2 COVID-19 vaccine doses before joining).
• You have a known allergy to the study drug or any of its ingredients.
• You have a second active cancer that has not been in remission for at least 1 year (some minor skin cancers and certain low-risk cancers may be exceptions — confirm with trial site).
• You have a serious medical or mental health condition that would prevent you from understanding the consent process or safely receiving treatment.
• You have a serious uncontrol