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:

• People aged 18 to 75 years old (including those who are exactly 18 or 75)
• People who are able to fully understand the study, sign a consent form willingly, and follow the study procedures and scheduled visits
• During the dose escalation phase — Non-small cell lung cancer (NSCLC): People with NSCLC confirmed by lab tissue or cell testing, whose cancer cannot be surgically removed, has come back, spread, or is locally advanced, who have specific gene changes (EGFR or ALK) and whose cancer got worse after, or who could not tolerate, standard targeted drug treatment, and who do not have certain other known gene changes (ROS1, NTRK, BRAF, RET) for which approved treatments already exist
• During the dose escalation phase — Endometrial cancer: People with endometrial cancer (of various specific types) confirmed by lab testing, whose cancer cannot be surgically removed, has come back, spread, or is locally advanced, and who have not previously received systemic (whole-body) anti-cancer treatment (not counting pre- or post-surgery treatments)
• During the dose expansion phase — Non-small cell lung cancer (NSCLC): People with non-squamous or squamous NSCLC confirmed by lab testing, whose cancer cannot be surgically removed, has come back, spread, or is locally advanced, who test negative for EGFR and ALK gene changes, who have no other known gene changes with approved targeted treatments, and who have not previously received systemic anti-cancer treatment (confirm with trial site for specific rules around prior surgery-related treatments)
• During the dose expansion phase — Endometrial cancer: People with endometrial cancer (of various specific types) confirmed by lab testing, whose cancer cannot be surgically removed, has come back, spread, or is locally advanced, and who have not previously received systemic anti-cancer treatment (confirm with trial site for specific rules around prior surgery-related treatments)
• People who have not received any anti-cancer treatment or other clinical trial drugs in the 4 weeks before starting this study (2 weeks or 5 drug half-lives for certain targeted drugs, whichever is longer), and who have completed certain types of radiotherapy at least 2–4 weeks beforehand
• People who have at least one measurable tumour that can be assessed using standard imaging criteria
• People with a performance status score of 0 or 1 on the ECOG scale, meaning they are either fully active or have some limits on heavy physical activity but can still do light work (confirm with trial site)
• People whose estimated life expectancy is at least 12 weeks
• People whose blood test results meet the required levels for blood cell counts, kidney function, liver function, blood clotting, and urine protein (confirm specific values with trial site)
• People whose side effects from any previous cancer treatment have largely resolved to a mild level (with some exceptions such as hair loss)
• People of childbearing potential who agree to use effective contraception during the study and for 3 months after the last dose; women of childbearing potential must have a negative pregnancy test during the screening period

Who may not be able to join:

• People who have brain metastases causing neurological symptoms (those with stable, symptom-free brain metastases who meet specific treatment and monitoring conditions may still be considered — confirm with trial site)
• People with active autoimmune diseases, or a history of autoimmune disease requiring systemic treatment within the past 2 years (some exceptions apply — confirm with trial site)
• People who have taken high-dose steroid medications or other immune-suppressing drugs at specific levels within 2 weeks before screening (some exceptions for certain topical or preventive uses — confirm with trial site)
• People with certain active infections, including infections needing more than 7 days of antibiotic treatment within 2 weeks before screening, active tuberculosis, HIV-positive status, or active hepatitis B or C (those with inactive hepatitis B or cured hepatitis C may still be considered — confirm with trial site)
• People who have previously received immune checkpoint inhibitor drugs combined with anti-blood vessel therapies (such as anti-PD-1/PD-L1 antibodies combined with anti-VEGF treatments or certain targeted drugs like anlotinib)
• People with a history of severe allergic reactions, previous serious immune-related side effects (grade 3–4) from similar treatments, or known allergies to the study drug components or chemotherapy drugs used in this trial
• People with high blood pressure that remains uncontrolled despite standard treatment (systolic 150 mmHg or higher, or diastolic 100 mmHg or higher)
• People with a history of blood clots in arteries or deep veins in the past 6 months, or signs or history of bleeding problems in the past 2 months
• People with bleeding or clotting disorders (past or current)
• People with a past history of heart muscle inflammation, heart muscle disease, or dangerous heart rhythm problems, or who have had serious heart or brain blood vessel events in the past 6 months (such as heart attack, serious heart failure, stroke, or related conditions)
• People with certain bowel conditions or disorders that could lead to bleeding or perforation of the gut (such as bowel obstruction, active Crohn's disease, ulcerative colitis, unhealed ulcers or wounds, or abdominal abscesses within the past 6 months); people with chronic Crohn's disease or ulcerative colitis are excluded even if currently inactive (confirm with trial site)
• People who have had a perforation or abnormal channel (fistula) in the digestive tract or urinary/reproductive system that has not fully healed after surgery
• People with a significant blockage of the kidney drainage system that has not been relieved by a medical procedure
• People with poorly controlled fluid build-up in body cavities (such as around the lungs, heart, or abdomen) that requires repeated draining
• People whose tumour, as seen on scans, has grown into or surrounds major blood vessels in a way that could risk serious bleeding (applies to the lung cancer group)
• People who had a sudden worsening of chronic obstructive pulmonary disease (COPD) within 1 month before their first dose
• People currently taking or who have recently taken blood thinners such as warfarin, heparin, dabigatran, rivaroxaban, or platelet-inhibiting drugs such as aspirin or clopidogrel within 7 days before the first study treatment
• People who have had major surgery, an open biopsy, or significant injury within 4 weeks before starting the study, or who are expected to need major planned surgery during the study; or who have had a minor invasive procedure within 1 week before starting (except for placement of a vascular access device)
• People with past or current lung conditions such as interstitial lung disease, pneumoconiosis, or severe lung function problems that could interfere with detecting or treating drug-related lung side effects
• People who are pregnant or breastfeeding
• People who have previously had an organ transplant or bone marrow/stem cell transplant from a donor
• People who have had another separate cancer in the past 5 years (some early-stage or fully cured cancers are excepted — confirm with trial site)
• People who have received a live virus vaccine within 30 days before screening
• People with advanced non-squamous NSCLC who cannot tolerate a chemotherapy combination of pemetrexed and carboplatin
• People with advanced squamous NSCLC or endometrial cancer who cannot tolerate a chemotherapy combination of paclitaxel and carboplatin
• People whom the trial investigators consider unsuitable for other reasons

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