Phase 2 Endometrial 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:

• Adults aged 18 or older.
• People diagnosed with one of the following cancer types: triple-negative breast cancer (TNBC) that has spread to other parts of the body; a type of lung cancer called non-small cell lung cancer (NSCLC) adenocarcinoma that has spread and has not responded to previous treatments; endometrial cancer (cancer of the lining of the uterus) that is advanced, has come back, or has spread; or high-grade ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
• People whose cancer has continued to grow or spread after their most recent treatment, as confirmed by imaging scans.
• People whose cancer can be measured on a scan (at least one tumour large enough to be tracked over time).
• People who are in reasonably good general health, rated as fully active or restricted only in physically strenuous activity (this is measured on a scale called ECOG performance status of 0 or 1).
• People expected to survive at least 3 months after starting the study drug.
• People whose kidneys are working well enough, as shown by blood or urine tests meeting specific thresholds.
• People whose bone marrow is producing enough blood cells, as shown by blood test results meeting specific thresholds.
• People whose liver is functioning well enough, as shown by blood test results meeting specific thresholds.
• People who have waited the required time since their last cancer treatment before starting the study drug (the waiting period varies depending on the type of treatment received).
• People who have had a blood clot in a vein (DVT) within the last 3 months and are already on a stable dose of blood-thinning medication for at least 2 weeks before starting the study drug.
• People who have had major surgery and have fully recovered before starting the study drug.
• People whose side effects from previous cancer treatment or radiation have mostly resolved (down to mild or lower), with the exception of mild nerve tingling/numbness, low red blood cell counts above a certain level, and hair loss.
• People who are willing and able to follow all parts of the study plan.
• People who provide written agreement (informed consent) before any study-related tests begin.
• People with a tumour tissue sample available for laboratory testing (an archived tissue block, recently prepared slides, or a fresh biopsy taken during the screening period).
• For participants taking the study drug combined with another drug called lenvatinib: people whose blood pressure is adequately controlled (at or below 150/90 mmHg) and has been stable on their current blood pressure medications for at least one week before starting the study drug.
• For ovarian, peritoneal, or fallopian tube cancer participants specifically: cancer that stopped responding to platinum-based chemotherapy within a defined timeframe, and who have received a limited number of prior treatment lines as specified by the trial.
• For endometrial cancer participants specifically: people who may have previously received immunotherapy (or are not suitable for it) and have had no more than 2 prior treatment regimens for advanced or metastatic disease (not counting adjuvant therapy completed more than 6 months before the cancer returned).

Who may not be able to join:

• People with certain rare subtypes of uterine cancer, including endometrial leiomyosarcoma, endometrial stromal sarcoma, or other soft tissue sarcomas.
• People who have previously been treated with any drug that targets the folate receptor, except for a specific drug called mirvetuximab soravtansine in certain circumstances (confirm with trial site).
• People with ovarian cancer whose disease progressed during their very first course of platinum-based chemotherapy (called platinum-refractory disease).
• People currently taking part in another clinical trial or who have taken an experimental drug within the past 28 days (or within 5 times the half-life of that drug, whichever applies).
• People with cancer that has spread to the brain or the lining around the brain, unless the brain metastases have been treated, have been stable on two consecutive brain scans for at least 4 weeks, and steroid medication for this has been stopped for at least 2 weeks before starting the study drug.
• People diagnosed with cancer that has spread to the membranes surrounding the brain and spinal cord (meningeal carcinomatosis).
• People who have had another separate cancer requiring treatment (other than surgery alone) or that has shown signs of returning within the 2 years before starting the study, with the exception of certain skin cancers or completely removed non-invasive cancers.
• People with significant heart problems, including a history (within the past 6 months) of serious heart failure, unstable chest pain, heart attack, stroke, or a heart rhythm problem that caused instability — or, for those in the lenvatinib combination group, an arterial blood clot within the past 12 months or reduced heart pumping function below 50%.
• People with a significantly abnormal heart electrical reading (ECG), particularly a prolonged QT interval above a certain threshold, or a history of certain heart rhythm risk factors, or who are taking medications known to prolong the QT interval.
• People who are known to be HIV positive.
• People with active hepatitis B or C infection confirmed by blood tests.
• People who are pregnant or breastfeeding.
• Women who are capable of becoming pregnant and have not been using a highly effective form of contraception for at least 28 days before joining the study, or who do not agree to continue using highly effective contraception throughout the study and for 7 months after the last dose of the study drug.
• Men (in the dose-escalation part) who have not had a confirmed vasectomy or whose female partners do not meet contraception requirements, or who do not agree to use condoms throughout the study and for 4 months after the last dose if their partner is pregnant; sperm donation is not permitted during or for 4 months after the study.
• People with abnormal lung function test results below the required thresholds.
• People with current or previous interstitial lung disease (ILD) or pneumonitis (lung inflammation) of any severity, including cases caused by previous cancer treatments.
• People with a current lung infection, or a history of viral pneumonia (including COVID-19) with remaining abnormalities visible on imaging scans.
• People with other significant lung conditions, including pulmonary embolism, asthma, COPD, or restrictive lung disease, or who are taking medications known to significantly increase the risk of lung inflammation.
• People with significant fluid build-up around the lungs or heart requiring drainage, or around the abdomen requiring a shunt.
• People who have had a lung removed (pneumonectomy).
• People with a history of radiation therapy to the chest area (those with a history of chest wall radiation only, such as from past breast cancer treatment, may be considered if it was completed more than 2 years before starting the study — confirm with trial site).
• People with autoimmune, connective tissue, or inflammatory conditions (such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis) that are known or suspected to involve the lungs.
• People with a known history of active tuberculosis (TB).
• People who are scheduled for any major surgery during the study period.
• People with a currently active, significant infection requiring antibiotic or antiviral treatment within 2 weeks before the first dose of the study drug.
• People who have received a live vaccine within 4 weeks before the first dose, or who are expected to need one during the study (inactivated vaccines and non-live flu or COVID-19 vaccines are permitted).
• People with a known severe allergic reaction to monoclonal antibodies, or who cannot take corticosteroids or any ingredient in the study drug.
• People with known intolerance to the components of the study drug.
• People with any other medical or personal condition that the investigator believes would make participation unsafe or unsuitable.
• People taking medications that are not permitted alongside the study treatment, unless those medications were stopped at least 7 days before enrolment.
• People with known psychiatric conditions or substance use disorders that would make it difficult to follow the study requirements.
• For participants in the lenvatinib combination group specifically: significant protein in the urine; a condition affecting the absorption of oral medications in the gut; inability to swallow oral medication; major surgery within 3 weeks before the first dose; a serious wound, ulcer, or bone fracture that has not healed; a pre-existing severe fistula (an abnormal connection between body parts); or imaging evidence that the tumour is growing into or around a major blood vessel.

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