Phase 1 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 who have been diagnosed with endometrial cancer that has come back, and whose cancer has a specific type of gene change (called a RAS pathway mutation, which includes changes in genes such as KRAS, NRAS, HRAS, BRAF, MEK1, or MEK2), confirmed by a laboratory test on a tissue or cell sample. Any type of endometrial cancer is accepted.
• People who have previously been treated with a type of cancer drug that works with the immune system (called immune checkpoint inhibitor therapy), either on its own or combined with other treatments.
• People who have had any number of previous cancer treatments, including previous use of a type of drug called a MEK inhibitor.
• People who are able to understand and willing to sign a consent form agreeing to take part in the study.
• People who are willing and able to follow the study schedule, including attending appointments and completing follow-up visits.
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work).
• Women who could become pregnant must have a negative pregnancy test within 72 hours before starting the study, and must agree to use an approved form of contraception during the study and for 3 months after the last dose. Approved methods include tubal ligation or hysterectomy, a partner who has had a vasectomy, or condoms used with spermicide. People who are not sexually active during the full study period and washout period may also meet this requirement. Hormonal contraception is not recommended for this study. This requirement applies to female participants from the onset of menstruation (as early as age 8) up to age 55, unless certain conditions apply — such as having gone through menopause, having had a hysterectomy or certain surgical procedures, or having confirmed ovarian failure following whole pelvic radiation therapy (confirm with trial site).
• People whose cancer can be measured on a scan, according to a standard set of measurement rules called RECIST v1.1.
• People aged 18 years or older.
• People whose blood, liver, and kidney test results meet minimum levels set by the trial (confirm with trial site for specific values).
• People whose muscle enzyme levels (a substance called CPK) are within an acceptable range.
• People whose heart is pumping well enough, as shown by a heart scan, and whose heart's electrical activity falls within an acceptable range on a heart tracing (ECG). People with certain heart rhythm conditions (right or left bundle branch block) may still be considered (confirm with trial site). People with a known history of heart disease should have a heart function assessment and would need to be rated as Class I or II and Stage A or B on a standard heart health scale.
• People joining the dose expansion part of the trial must be willing to have a tissue sample (biopsy) taken before and during treatment.

Who may not be able to join:

• People who are pregnant or currently breastfeeding.
• People whose endometrial cancer contains a sarcoma component, except for a type called carcinosarcoma.
• People who have had radiation, chemotherapy, immunotherapy, or any other cancer treatment within 2 weeks before the study start date.
• People who have taken part in another interventional cancer clinical trial within 3 weeks before the study start date.
• People who have had major surgery within 4 weeks before the study start date.
• People with a history of a serious heart failure condition rated Class 3 or higher on a standard medical scale, or who have had a heart attack within the past 3 months.
• People with a history of serious lung conditions, such as severe obstructive lung disease, high blood pressure in the lungs, or lung scarring, as determined by the treating doctor.
• People with a history of a serious muscle breakdown condition called rhabdomyolysis, as determined by the treating doctor.
• People who previously used a MEK inhibitor and experienced a severe (Grade 4) side effect considered related to that drug, or who are still experiencing such a side effect.
• People who have an infection that is not under control and requires intravenous antibiotics, antivirals, or antifungal medicines within one week before the first dose. People with a controlled infection or taking preventive antibiotics may still be considered (confirm with trial site).
• People with an active Hepatitis B or Hepatitis C infection that shows a detectable level of virus in the blood. People with HIV who have a detectable viral load are also excluded; those with an undetectable viral load may be considered (confirm with trial site).
• People who have a condition that would significantly prevent them from absorbing or swallowing oral (by mouth) medication, as determined by the treating doctor.
• People with a psychiatric illness or personal circumstances that would make it difficult to follow the study requirements.
• People with brain lesions that are causing symptoms.
• People with a significant bleeding disorder or blood clotting problem (not related to blood-thinning medication). People who have had a blood clot in a vein or lung and are already on appropriate blood-thinning treatment may still be considered (confirm with trial site).
• People who have had a significant episode of coughing up blood within one month before enrolling in the study.
• People with a wound, ulcer, or bone fracture that is not healing.
• People with a known allergic reaction to the study drugs (defactinib, avutometinib, everolimus, or related medicines).
• People currently taking warfarin (a blood-thinning medication). People taking warfarin for a blood clot condition may be considered if their medication can be safely switched to a different type of blood thinner and their blood test results meet the required level before the first study dose (confirm with trial site).
• People currently using certain medications, supplements, herbal remedies, or foods — including grapefruit, grapefruit juice, Seville oranges, and star fruit — that are known to interact with the study drugs. This applies to substances taken within a set period before the first dose (confirm with trial site for specific timing and a list of affected substances).
• People with certain eye conditions, including a history of glaucoma, a history of blockage of a vein in the eye (retinal vein occlusion), uncontrolled high blood pressure, uncontrolled diabetes, certain retinal conditions, high pressure inside the eye, or other significant eye problems that could increase risk or interfere with monitoring during the study (confirm with trial site).
• People with active or ongoing significant corneal (front of the eye) disorders that require ongoing treatment or that would make it difficult to monitor eye health during the trial (confirm with trial site).
• People with a severe skin condition that has required systemic (whole-body) treatment within one year before the first study dose, as determined by the treating doctor.

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