Phase 2 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 with advanced or metastatic hormone receptor-positive, HER2-negative breast cancer that has continued to grow after treatment with a specific type of cancer drug called a CDK4/6 inhibitor (given either after surgery or for advanced disease)
• People with advanced or metastatic high-grade ovarian, fallopian tube, or peritoneal cancer that did not respond well to platinum-based chemotherapy, and whose tumour has a specific genetic change called CCNE-1 amplification, and whose cancer has grown after standard treatment
• People with any advanced or metastatic solid tumour that has a CCNE-1 amplification, and whose cancer has grown after standard treatment, or who were unable to tolerate standard treatment, or for whom standard treatment was not considered appropriate
• People who have at least one tumour that can be measured on a scan, in an area that has not previously been treated with radiation
• People who are fully active or have only minor limitations in daily activity (this is measured using a standard scale called ECOG performance status, scored 0 or 1)
• People whose blood counts and organ function meet the required levels — including haemoglobin, white blood cell count, platelets, kidney function, and liver function — as confirmed by laboratory tests
• People who have a negative pregnancy test result

Who may not be able to join:

• People who have previously been treated with a CDK2, CDK4/6, or CDK2/4/6 inhibitor drug
• People who have cancer that has spread to the brain or spinal cord and is causing worsening neurological symptoms, or who have needed steroid medication to control brain disease within the past 4 weeks
• People with known bleeding in the brain or a condition that causes abnormal bleeding
• People whose cancer has spread to internal organs in a way that is causing a medical emergency (visceral crisis), or has spread through the lymph vessels of the lungs, or has spread to the membranes surrounding the brain and spinal cord
• People with active lung inflammation (interstitial lung disease) from any cause, including from previous drugs or radiation, within 28 days before starting the study treatment
• People with certain heart rhythm abnormalities, including a prolonged QT interval on a heart tracing (ECG), a personal history of related heart rhythm problems, or a family history of prolonged QT syndrome
• People with cardiovascular disease, including high blood pressure, that is not well controlled
• People with a history of another cancer, unless it was an adequately treated skin cancer, a cancer that was fully cured (such as certain cervical, prostate, or bladder cancers), or another solid tumour that was fully cured with no signs of disease for at least 3 years
• People with known HIV, active hepatitis B, active hepatitis C, active tuberculosis, or an active COVID-19 infection (symptoms and a positive test)
• People who need to take a medication or herbal remedy that is not permitted in this trial and cannot stop taking it at least 2 weeks before starting the study drug
• People who have a major surgical procedure planned within 28 days of the first study drug dose (note: minor procedures such as biopsy or catheter placement are not considered major surgery)
• People who are unwilling or unable to follow the trial schedule, take study drugs as planned, attend laboratory visits, or follow study rules
• People who have had full-dose radiation therapy within 28 days before joining, or lower-dose (palliative) radiation within 2 weeks before joining
• People who have received systemic cancer treatment within 21 days before the first study drug dose, or within 5 half-lives of that treatment (whichever is the shorter period)
• People who have previously had radiation to more than 25% of their bone marrow
• People who have previously had high-dose chemotherapy that required a stem cell transplant
• People who have taken part in another clinical trial using an investigational drug within 4 weeks before joining this study
• People with a known or suspected allergy or sensitivity to the study drug INX-315, or to fulvestrant or abemaciclib
• People who have difficulty swallowing tablets or conditions that would affect how oral medications are absorbed, such as active gut inflammation, severe nausea or vomiting that is not controlled by anti-nausea medication, bowel obstruction, malabsorption conditions, chronic diarrhoea, known diverticular disease, or previous stomach or bowel surgery
• People with serious or uncontrolled medical conditions that, in the judgement of the trial doctor, would make participation unsafe — for example, severe breathing difficulties, significant lung disease, or pre-existing bowel conditions such as Crohn's disease or ulcerative colitis

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