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 been diagnosed with advanced colorectal cancer, stomach/gastroesophageal cancer, or ovarian cancer that has gotten worse or is no longer responding to standard treatments. For colorectal cancer, lab tests must show the tumor has a specific characteristic called "mismatch repair proficient" (confirm with trial site for what testing is needed).
• People whose cancer has continued to grow after at least one previous cancer treatment, but who have not had more than three previous treatment courses. For the Phase 1b part of the trial only, people with gastroesophageal cancer must have already received a type of cancer treatment called an immune checkpoint inhibitor that did not work.
• People who have at least one tumor that can be injected during the trial and meets specific size requirements — either a liver tumor between 1.0 and 6.5 cm with total liver tumors taking up less than one-third of the liver, a lymph node between 1.5 and 6.5 cm, or another solid tumor between 1.0 and 6.5 cm. No single tumor anywhere in the body (including ones that won't be injected) can be larger than 6.5 cm.
• People who are generally well enough to carry out daily activities with little or no limitation, as measured by a standard medical scale called the ECOG performance scale (score of 0 or 1).
• People whose liver, kidneys, and other organs are working well enough, based on blood tests taken within 3 days before starting treatment.
• People aged 18 to 85 years at the time they sign the consent form.
• People who are willing to use reliable contraception (or abstain from sexual activity) starting from the first dose of study treatment until 120 days after the last dose. This applies to both women who could become pregnant and men who could father a child.
• People who have given written agreement (informed consent) to take part in the trial, either themselves or through a legal representative.
• Women who could become pregnant must have a negative pregnancy test within 3 days before the first dose. If the urine test result is unclear, a blood pregnancy test will be needed.
• People who have mostly recovered from side effects of previous cancer treatments, with side effects at a mild level or better before joining the trial. People with slightly more persistent but not medically significant side effects may also be considered, with approval from the trial sponsor.
• People who are expected to live for more than 6 months.

Who may not be able to join:

• People whose doctor considers them a candidate for liver surgery or other liver-directed treatments aimed at curing the cancer, or who need a different type of systemic (whole-body) cancer treatment.
• People who have a significant build-up of fluid in the abdomen (a condition called ascites) at a moderate or severe level.
• People with other serious uncontrolled health conditions — such as uncontrolled high blood pressure, unstable chest pain, a heart attack or stroke within the past 6 months, or uncontrolled mental health conditions or substance use — that could interfere with taking part in the trial.
• People who need regular, ongoing use of steroid medications above a low dose (more than 10 mg of prednisone or equivalent per day), or other medications that suppress the immune system, within 4 weeks before the first dose. Single doses of steroids used during imaging scans to prevent allergic reactions are allowed.
• People who have not fully recovered from major surgery, or whose surgery requiring general anaesthetic was completed less than 2 weeks before the first dose.
• People who have a bleeding or clotting disorder — either due to a medical condition or blood-thinning medications — that cannot be reversed with medical treatment.
• People whose tumors are located very close to an airway, major blood vessel, or spinal cord in a way that could be dangerous (as determined by the doctor).
• People whose cancer has spread in a widespread, scattered pattern without any suitable tumors available for injection.
• People who have previously received an immune checkpoint inhibitor (a type of immunotherapy) must have finished that treatment at least 28 days before starting this trial, must have experienced disease progression on that treatment, and must not have had any serious immune-related side effects (Grade 3 or above) from it. Certain managed side effects such as thyroid problems, Type 1 diabetes, or mild skin reactions like vitiligo may be exceptions (confirm with trial site). A history of a Grade 2 serious allergic infusion reaction to an immune checkpoint inhibitor, even with preventive treatment, is also a reason a person may not be able to join.
• People who need other cancer treatments not allowed under this trial's rules. Those treatments must have been stopped at least 21 days or 5 half-lives (whichever is longer) before starting the trial.
• People who are currently taking part in another clinical trial involving an experimental treatment or device within 4 weeks of the trial start date.
• People who have received a live vaccine within 4 weeks, or any other vaccine (including flu shots and mRNA vaccines) within 2 weeks, of the planned first treatment date.
• People who have active, symptomatic, or growing cancer spread to the brain or spinal cord. People with treated and stable brain metastases may be considered if they have been off steroids for at least 2 weeks and have had stable scans for at least 3 months before the trial start.
• People with a known diagnosis of HIV, active Hepatitis B, or active Hepatitis C.
• People with a severe or uncontrolled active infection that requires treatment.
• People who have had another type of cancer within the past 3 years, with some exceptions for certain low-risk or likely-cured cancers such as certain skin cancers, early bladder cancer, or certain early-stage cancers of the prostate, cervix, or breast (confirm with trial site).
• People with a history of serious lung inflammation (interstitial lung disease or pneumonitis) caused by a drug that required steroid treatment, unless it was caused by radiation therapy.
• People who have previously had an organ transplant, including bone marrow or stem cell transplants.
• People with an active or documented autoimmune disease in the past 2 years that required systemic (whole-body) treatment.
• People with a known condition that causes a weakened immune system from birth (primary immunodeficiency).
• People who have signs of a small bowel obstruction (a blockage in the intestine) on a CT scan, or who were hospitalised for this condition within the past 3 months.
• People with any other health condition, treatment history, or lab result that the treating doctor believes could affect trial results, interfere with full participation, or would not be in the person's best interest.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period, from the first screening visit through 120 days after the last dose.

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