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 who are able to give signed, written consent to participate.
• People who have been confirmed through a tissue sample (biopsy) to have high-grade endometrial (uterine) cancer.
• For Arms 1 and 2: People with high-grade uterine cancer of various tissue types, including Grade 3 endometrioid, serous, carcinosarcoma, clear-cell, mixed types, or Grade 2 endometrioid with a specific gene mutation called p53.
• For Arms 3 and 4: People with serous carcinoma, or mixed tumours where serous carcinoma is the main component, or carcinosarcoma where the cancer cell type is serous carcinoma.
• For Arms 1 and 2: People who have previously received platinum-based chemotherapy, a type of immunotherapy called anti-PD-(L)1, and no more than three prior rounds of systemic (whole-body) treatment.
• For Arms 3 and 4: People who have previously received platinum-based chemotherapy, anti-PD-(L)1 immunotherapy, and no more than two prior rounds of systemic treatment.
• People whose cancer has spread to other parts of the body and has continued to grow or worsen during or after at least one prior treatment.
• People who have at least one measurable area of cancer that can be seen on a scan taken within 28 days before starting treatment, with scan evidence showing the cancer has continued to grow after the most recent treatment.
• For Arms 1 and 2 (excluding sites in EU countries): People who are willing to have a new tissue sample (biopsy) taken from a tumour that has not been previously treated with radiation, during the 28-day screening period.
• For Arms 3 and 4: People who can provide stored tumour tissue — either as a tissue block or at least 20 prepared slides — collected before or during screening.
• People whose side effects from previous treatments have largely settled, with some exceptions accepted (such as hair loss, certain hormone-related effects from prior immunotherapy at a mild-to-moderate level, and mild-to-moderate nerve-related effects from prior chemotherapy).
• People who are generally well enough to carry out light activity and care for themselves (rated 0 or 1 on a standard health and activity scale used in cancer research).
• People whose doctor estimates they have a life expectancy of more than 3 months.
• People whose blood test results show that their bone marrow, kidneys, liver, and other organs are functioning at adequate levels as defined by the trial (confirm specific values with trial site).
• People whose blood clotting levels fall within acceptable ranges, or who have been on a stable dose of blood-thinning medication for at least one month.

Who may not be able to join:

• People who have brain metastases (cancer that has spread to the brain) causing symptoms that require more than 10 mg per day of a steroid called prednisolone — though people with previously treated, stable brain metastases who meet certain conditions may still be considered (confirm with trial site).
• People whose uterine tumour is a mesenchymal type (a specific tissue type of uterine cancer).
• People who have had a build-up of fluid in the abdomen or chest requiring drainage for treatment purposes within 4 weeks before screening, or who have such a procedure planned before the first dose.
• People who have received any systemic cancer treatment or radiation therapy within 3 weeks before the first dose of the trial drug.
• People with HIV, hepatitis B, or hepatitis C infection that is not considered under control (confirm specific criteria with trial site).
• People with a significant history of blood clotting problems or abnormal bleeding.
• People with certain heart or blood pressure conditions, including uncontrolled high blood pressure, certain heart rhythm problems, a history of serious heart events (such as heart attack or stroke within the past 6 months), or abnormal heart electrical readings (confirm specific details with trial site).
• People who have had major surgery within 4 weeks before screening.
• People who have had a bowel blockage related to their cancer within the last 4 weeks, or who currently have symptoms or scan findings suggesting a bowel blockage.
• People who have previously been treated with a type of drug called a CHK1 inhibitor, including the trial drug ACR-368 itself.

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