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:

• Phase I: Women with gynecological cancers that have continued to grow or spread after standard treatments, and for whom no other effective treatment is available, aged 18 to 75 years old.
• Phase II: Women of reproductive age (recommended age 40 or under) who want to preserve their ability to have children and understand the possible risks involved.
• Phase II – Cervical Cancer Group: Women with a confirmed diagnosis of certain types of cervical cancer (squamous cell, adenocarcinoma, or adenosquamous) at specific stages, where scans show the cancer has not spread to the upper part of the uterus, and vaginal involvement (if any) is less than 2 cm.
• Phase II – Endometrial (Uterine Lining) Cancer Group: Women with confirmed abnormal or early-stage uterine lining cancer (specific low grades and stages) that has not responded to hormone therapy or has a specific genetic feature, and where scans confirm the cancer is limited to the uterine lining or just the surface layer of the uterine wall.
• Being in generally good physical condition and able to carry out daily activities with little or no limitation (as assessed by a standard medical scale).
• Having an expected survival of at least 3 months.
• Having blood, liver, kidney, and clotting test results within acceptable ranges (specific values will be checked by the trial team).
• Having a negative pregnancy test at the start of the trial (if you could potentially become pregnant), and agreeing to use reliable contraception from the start of the trial until at least 3 months after the last dose.
• Being willing and able to give written informed consent after fully understanding what the trial involves.

Who may not be able to join:

• People with a history of serious heart or stroke-related conditions, including certain irregular heart rhythms, recent heart attack, heart failure, stroke, or uncontrolled high blood pressure within the past 6 months.
• Phase II: Women where scans show the cancer has spread to lymph nodes in the abdomen, or (for cervical cancer) into the upper uterus, or (for uterine cancer) deeper into the uterine wall, the cervix, or beyond the uterus.
• People who have had a significant build-up of fluid in the body (such as around the lungs or abdomen) requiring treatment within the past 4 weeks.
• People with a history of autoimmune disease, immune system problems, or who have had an organ transplant.
• People with an active infection currently requiring treatment, or an unexplained fever above 38.5°C at the time of screening.
• People who test positive for HIV or syphilis, or who have active hepatitis B or C infections (certain exceptions may apply — confirm with trial site).
• People with uncontrolled seizures, nervous system disorders, or psychiatric conditions that affect thinking or understanding.
• People who still have significant side effects from previous cancer treatments that have not sufficiently resolved.
• People currently needing antiviral medication, or who have taken antiviral drugs within 2 weeks before the first dose.
• People who have received certain cancer treatments too recently before joining the trial (specific time limits depend on the type of treatment — confirm with trial site).
• People who have taken high-dose steroid tablets or other immune-suppressing medications within the past 14 days (some exceptions apply — confirm with trial site).
• People who have previously been treated with oncolytic viruses or oncolytic bacteria (a specific type of cancer therapy).
• People who have received any vaccine within 28 days before the first dose.
• Women who are pregnant or breastfeeding.
• People with a history of severe allergies or a tendency toward serious allergic reactions.
• Anyone the trial doctors consider unsuitable for other medical reasons.

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