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 fully understand the trial's purpose, risks, and methods, and who are willing to sign a consent form before any procedures begin.
• Men or women between the ages of 18 and 75.
• People who have been diagnosed with an advanced solid tumour (such as colorectal, lung, ovarian, or cervical cancer, among others) confirmed by laboratory tissue or cell testing, where standard treatments are no longer available or have stopped working or caused intolerable side effects.
• People who have at least one tumour located outside the brain that can be measured on a CT scan or MRI taken within the past 4 weeks, and that is suitable for a direct injection into the tumour.
• People whose general physical functioning is rated 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limits on physically demanding activity (confirm with trial site).
• People who are expected to live for at least 3 months.
• People whose blood, liver, kidney, and heart function test results meet specific levels measured within 7 days before the first dose — including adequate blood cell counts, normal clotting levels, liver enzyme levels within acceptable ranges, kidney function above a certain threshold, and a heart rhythm measurement within normal limits (confirm with trial site for specific values).
• People who are able to communicate with the research team and are willing and able to follow the study requirements.

Who may not be able to join:

• People who have been diagnosed with another cancer in the past 5 years, unless it was a low-risk type such as certain treated skin cancers or carcinoma in situ.
• Women who are pregnant or breastfeeding.
• People who have had two or more drug allergies, or who have a known sensitivity to similar products or ingredients used in this trial.
• People who have previously received a smallpox vaccine and had a severe reaction or side effects from it.
• People who have previously been treated with lysosomal virus therapy, stem cell therapy, or gene therapy.
• People who have taken another experimental drug or participated in another clinical trial within the 28 days before the first dose.
• People who have received cancer treatments such as radiation therapy (other than palliative), chemotherapy, biological therapy, hormone therapy, or immunotherapy within 28 days before the first dose; or certain targeted cancer medicines within 14 days (or five times the drug's half-life, whichever is longer); or herbal medicines with anti-cancer effects within 14 days before the first dose.
• People who have had surgery or a medical procedure (other than a tumour biopsy or needle sample), or who have wounds, ulcers, or fractures that have not fully healed, within 28 days before the first dose.
• People who have taken high-dose steroid medicines or immune-suppressing medications within 28 days before the first dose, or who are currently taking certain antiviral medicines — though some exceptions apply, such as short-term steroid use for allergies, inhaled or topical steroids, or stable antiviral treatment for hepatitis B (confirm with trial site).
• People whose brain tumour spread (CNS metastases) is causing active symptoms or is not well controlled — though people whose brain metastases have been stable for more than 4 weeks without needing steroids or other brain-targeted treatments may be considered (confirm with trial site).
• People with significant or rapidly worsening fluid build-up in the abdomen, around the heart, or around the lungs.
• People with a serious heart condition, including severe irregular heartbeats, significant heart block, Grade III–IV heart failure, or recent events such as heart attack, stroke, heart failure, or aortic dissection within the past 6 months; or uncontrolled high blood pressure remaining above 160/100 mmHg despite treatment.
• People who have had a serious bleeding event in the past 6 months, or who have active significant bleeding, abnormal blood vessels, tumour invasion of blood vessels, an active stomach ulcer, or high-risk varicose veins in the oesophagus.
• People with a history of severe coughing up of blood.
• People who still have side effects from previous cancer treatment that have not returned to a mild level (Grade 1 or lower), except for hair loss.
• People with uncontrolled or severe infections currently requiring antibiotic treatment.
• People with an active or recurring autoimmune disease (such as lupus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, or others), or those at high risk due to having had an organ transplant requiring immune-suppressing medicines — though people with stable Type 1 diabetes on a fixed insulin dose, or autoimmune thyroid conditions managed with hormone replacement only, may be considered.
• People with a history of severe skin conditions affecting the whole body that required systemic treatment, such as eczema or atopic dermatitis.
• People who test positive for HIV.
• People with active hepatitis B or C infection — though people with past hepatitis C and a negative test at screening, or hepatitis B with a very low viral level, may be considered (confirm with trial site for specific thresholds).
• People who are unwilling to use appropriate contraception throughout the trial and during the follow-up period.
• People with a documented psychiatric condition that may affect their ability to follow the trial requirements.
• People whose cancer may require treatments other than the study drug being tested (GC001).
• People whose tumour is located near major blood vessels, important nerves, or airways, or in a position that makes a direct injection into the tumour too risky, as determined by the trial doctor.

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