Phase 1 Ovarian 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 or older who have been diagnosed with a confirmed recurrent (returned) cancer of a specific type, including: clear cell or endometrioid ovarian cancer (with at least 50% of the tumour being that cell type), low-grade (Grade 1) clear cell or endometrioid uterine (endometrial) cancer that cannot be cured or where the person has declined curative treatment, or platinum-resistant high-grade serous ovarian cancer (meaning the cancer came back or worsened within 6 months of finishing platinum-based chemotherapy)
• People whose ability to carry out daily activities is reasonably well-preserved, rated at level 0, 1, or 2 on a standard medical scale called the ECOG Performance Status
• People who have received between 1 and 3 prior chemotherapy treatments (for platinum-resistant high-grade serous ovarian cancer in Part I, up to 3 prior chemotherapy treatments after the cancer became platinum-resistant)
• People with a specific type of uterine cancer marked by certain genetic repair problems (MSI-H or dMMR) who have previously received an immune checkpoint inhibitor treatment
• People who have had unlimited prior hormonal therapy, targeted therapy (including immunotherapy), or anti-blood-vessel therapy
• People whose last chemotherapy was at least 3 weeks ago, and whose last radiation therapy was at least 2 weeks ago (radiation must not have covered more than 25% of the bone marrow)
• People with measurable or detectable cancer visible on scans (Part I requires either; Part II requires measurable disease by a standard system called RECIST 1.1)
• People whose blood counts and organ function meet specific minimum levels, including: haemoglobin at least 9 g/dL (without a blood transfusion in the past 28 days), white blood cell count (neutrophils) at least 1,500 cells/mm³, platelets at least 100,000 cells/mm³, kidney function (creatinine clearance) at least 50 mL/min, liver enzyme levels within acceptable ranges, and bilirubin within acceptable limits (a slightly higher level is permitted for people with a condition called Gilbert's disease)
• People with a history of heart disease or prior treatment with heart-affecting drugs, whose heart function is rated Class I or II on a standard heart health scale (NYHA classification)
• People who are able and willing to use effective contraception during the trial and for at least 6 months after the last dose, and who agree not to breastfeed during treatment and for 1 month after stopping (the study drugs carry unknown or known risks to a developing baby)
• People who have had another cancer in the past or at the same time, as long as that cancer or its treatment is unlikely to interfere with this trial's safety or results
• People who had brain metastases (cancer spread to the brain) that have been treated, show no signs of growth on follow-up scans, require no steroid medication, and have been stable for at least 1 month
• People who are able to swallow tablets and capsules whole, without chewing, crushing, or opening them
• People living with HIV who are on effective antiviral treatment and have had an undetectable viral load within the past 6 months
• People with chronic Hepatitis B who have an undetectable viral load while on appropriate treatment
• People with a history of Hepatitis C who have been successfully treated and cured, or who are currently on Hepatitis C treatment with an undetectable viral load
• People whose side effects from previous treatments have largely resolved to mild or baseline levels before starting the trial
• For Part II only: people whose tumour has been tested by a type of genetic sequencing (Next-Generation Sequencing) to determine the status of a gene called ARID1A, showing either a mutation (Cohort I) or a normal version of the gene (Cohort II)

Who may not be able to join:

• People currently participating in another clinical trial involving an investigational (unapproved) treatment
• People who have previously received treatments targeting ATR, ATM, CHK, BET, EZH2, or PI3K pathways
• People with a history of serious allergic reactions to drugs chemically similar to the study drugs ZEN003694 or M1774
• People taking proton pump inhibitors (a common type of heartburn/acid reflux medication), unless they are able to stop taking them at least 7 days before starting the trial
• People with a heart rhythm measurement (QTc interval) above 450 milliseconds that does not improve after correcting mineral (electrolyte) levels, or people with a family history of a heart condition called long QT syndrome
• People with a serious active infection that requires antibiotic treatment given through a drip (intravenously)
• People with certain inherited genetic conditions affecting DNA repair, including ataxia telangiectasia, Nijmegen breakage syndrome, Werner syndrome, Bloom syndrome, Fanconi anaemia, xeroderma pigmentosum, Cockayne syndrome, or trichothiodystrophy
• People who are pregnant or currently breastfeeding (people who stop breastfeeding may be considered for enrolment and must not restart breastfeeding until 1 month after finishing treatment)
• People taking certain medications that strongly affect how the body processes drugs through an enzyme called CYP3A4 (these must be stopped at least 7 days before starting the trial); certain other related medications should also be avoided or used only with close monitoring and approval from the study team (confirm with trial site)
• People taking blood-thinning medications called Factor Xa inhibitors (such as rivaroxaban or apixaban) or Factor IIa inhibitors (such as dabigatran), unless they are able to switch to a different type of blood thinner called low molecular weight heparin, or unless the study team approves continued use
• People with serious gut or digestive problems within the past 3 months, or ongoing conditions that could prevent the study drugs from being properly absorbed, such as severe nausea and vomiting, uncontrolled diarrhoea, known malabsorption, significant bowel surgery, gastric bypass surgery, use of a feeding tube, or a stomach drainage tube
• People who cannot stop taking medications that strongly block enzymes called CYP3A4 or CYP1A2, or medications that use pathways called hMATE1 or hMATE2-K (confirm with trial site)
• People who received radiation to more than 25% of their bone marrow

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