Phase 1 Endometrial Cancer Trial, Recruiting

Written by an AI model from the 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 are willing to sign a consent form agreeing to take part in the study.
• People who are willing to follow the study schedule, including all visits and treatment plans.
• People who have or have had a solid tumour that tested positive for a virus called HPV16.
• People between 18 and 75 years old at the time of signing the consent form.
• People whose general physical functioning is rated at a level where they are fully active or have only minor restrictions on physical activity (as assessed by a doctor), with no worsening over the previous 2 weeks.
• People whose life expectancy is estimated to be more than 12 weeks.
• People with HPV16-positive head and neck, cervical, or other cancers that have come back or spread, and whose cancer has continued to grow after standard treatments, or for whom no further standard treatments are available.
• People who have at least one tumour that can be measured on a scan at the start of the study.
• People whose blood cell counts and blood chemistry fall within specific ranges required by the study, without recent blood transfusions or certain blood-boosting medications (confirm with trial site for exact values).
• People whose liver enzyme levels are within acceptable ranges set by the study (confirm with trial site).
• People whose kidneys are functioning at an adequate level as measured by specific blood or urine tests (confirm with trial site).
• People whose blood clotting results fall within acceptable ranges set by the study (confirm with trial site).
• People whose heart pumping function is at least 50%, as measured by an ultrasound of the heart.
• People who agree to use effective contraception from the time of signing the consent form until 90 days after the last dose of the study treatment; women who could become pregnant must also have a negative pregnancy test within 7 days before the first dose.

Who may not be able to join:

• People who have previously received any HPV vaccination as a treatment (therapeutic vaccine), or who have received any live or weakened live vaccine within 4 weeks before the first dose.
• People who have had a life-threatening allergic reaction, or who are known to be allergic to any ingredient in the study treatment (TI-0093).
• People who are pregnant or breastfeeding, or who plan to donate eggs or sperm between signing the consent form and 90 days after the last dose.
• People who have another active cancer, with some exceptions for certain low-risk cancers that have been fully treated (confirm with trial site for which exceptions may apply).
• People who have cancer that has spread to the fluid around the brain or spinal cord, or who have active or recently symptomatic brain metastases within the past 28 days (some exceptions may apply for previously treated, stable brain metastases — confirm with trial site).
• People who have had severe lung inflammation (such as interstitial lung disease) within the 6 months before the first dose.
• People who have had major surgery within 4 weeks before the first dose.
• People who have had a serious blood clot in a deep vein or in the lungs within the 6 months before the first dose.
• People who have had active or significant bleeding — such as coughing up blood, gut bleeding, or bleeding stomach ulcers — within the 28 days before the first dose.
• People with significant alcohol dependence or drug misuse that cannot be stopped, or people with certain mental health conditions, as assessed by the investigator.
• People who have an active autoimmune disease, or who have needed high-dose steroids or immune-suppressing medications within the 4 weeks before the first dose (some conditions such as vitiligo, well-controlled thyroid conditions, or type 1 diabetes managed with replacement therapy may be excepted — confirm with trial site).
• People with serious or uncontrolled heart conditions, including significant heart failure, heart attack, heart rhythm problems, or uncontrolled high blood pressure during the screening period.
• People with active or uncontrolled infections, poorly controlled diabetes, uncontrolled asthma, or certain bowel conditions during the screening period.
• People with active hepatitis B (under certain conditions), active hepatitis C, active syphilis, or active tuberculosis during the screening period.
• People who have tested positive for HIV or have AIDS, or who have previously had an organ transplant or bone marrow/stem cell transplant from another person.
• People who have had a hole or abnormal opening in the bowel or reproductive tract within the 6 months before the first dose, unless fully recovered as judged by the investigator.
• People who have needed fluid drained from around the lungs, abdomen, or heart within the 2 weeks before joining the study.
• People who experienced severe immune-related side effects (Grade 3 or above) from a previous immunotherapy, or any immune-related side effect that led to stopping a previous immunotherapy.
• People who still have unresolved side effects from previous treatments that are above a mild level (with some exceptions such as hair loss or certain stable conditions — confirm with trial site).
• People who have no spleen or have significantly reduced spleen function due to a clot or infarction.
• People who have been taking steroid medications at moderate to high doses, or other immune-suppressing medications, within the 14 days before the first dose.
• People who have received certain immune-boosting medications (such as thymosin, interleukin-2, or interferon) within 4 weeks before the first dose.
• People who have recently received other cancer treatments, including chemotherapy, targeted therapy, immunotherapy, radiotherapy, hormone therapy, or certain other medications, within specific timeframes before the first dose (confirm with trial site for the exact timeframe relevant to each treatment type).
• People who have participated in another clinical trial and received an investigational treatment within 5 half-lives of that treatment or 4 weeks (whichever is longer) before the first dose.
• People with any other medical condition or abnormal test result that, in the investigator's judgement, could affect the safety of taking part or the reliability of the study results.

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