Phase 2 Oesophageal 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 cancer that has spread to other parts of the body or has grown in a way that cannot be surgically removed, and for which no treatment aimed at curing the disease is available.
• People whose cancer shows specific changes (alterations) in a biological pathway called AKT/PI3K/PTEN, detected by a test approved by the trial sponsor.
• People whose cancer can be measured or tracked using standard imaging guidelines (known as RECIST v1.1), with measurable disease required for the expansion stage of the trial.
• People who are reasonably well and able to carry out daily activities, as measured by a standard health scale (ECOG score of 0 or 1).
• People whose heart, liver, kidneys, and other organs are functioning at an adequate level.
• For the TER-2013 alone (monotherapy) arms: people with a confirmed solid tumour cancer, with specific cancer types required for the expansion stage — including ovarian cancer, cervical cancer, certain head and neck, lung, or oesophageal cancers, or endometrial adenocarcinoma.
• For the TER-2013 alone arms: people who have already received standard treatments suitable for their cancer type, or who could not tolerate or were not able to receive those treatments, and who have had no more than 3 prior treatment courses for the expansion stage.
• For the TER-2013 combined with fulvestrant arms: people with a confirmed type of breast cancer that is hormone receptor positive and HER2 negative (HR+/HER2-), that cannot be surgically removed or has spread.
• For the TER-2013 combined with fulvestrant arms: people who have previously been treated with a type of hormone therapy called an aromatase inhibitor (AI), and who have had no more than 3 prior treatment courses in the advanced or metastatic setting.

Who may not be able to join:

• People whose cancer has certain specific genetic mutations (in EGFR, KRAS, NRAS, HRAS, or BRAF) alongside the PI3K/AKT/PTEN pathway change.
• People with clinically significant problems with how their body manages blood sugar levels.
• People with active cancer spread to the brain, or cancer affecting the lining of the brain and spinal cord.
• People who have had a significant episode of coughing up blood or serious bleeding within 4 weeks before the start of the trial.
• People who have conditions that significantly affect how the body absorbs or processes food and medication, or who have nausea and vomiting that cannot be controlled with medication, in a way that may interfere with how the study drug is absorbed.
• People who have previously been treated with certain targeted drugs that work on the AKT, PI3K, or PTEN pathway, fulvestrant or similar drugs (SERDs), or mTOR inhibitors — with the specific restrictions depending on which part of the trial a person would be joining (confirm with trial site).
• Additional eligibility requirements defined in the trial protocol also apply (confirm with trial site).

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