Brief Summary
The purpose of this study is to examine the safety, anti-cancer activity, and how the body metabolises a new medication called EO1001.
Intervention/Treatment
- Drug: EO1001
Inclusion Criteria
- Male or female >= 18 years of age participants with confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of metastatic or advancedat a late stage, far along stage ErbB-1 (EGFR), ErbB-2 (HER2) and/or ERbB-4 (HER4) positive cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs who have relapsed after treatment with approved therapies and are unsuitable for further treatment with approved therapies or declined further treatment with approved therapies.
- Participants must sign informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..
- Participants must have measurable disease, defined as at least 1 unidimensional measurable lesion on an imagingtests that create detailed images of areas inside the body scan as defined by RECIST 1.1.
- Life expectancy of greater than 3 months.
- Acceptable organ function, as evidenced by the following laboratory data during screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening period:
- Adequate hepatic function as defined by bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN. Serum bilirubin must be less than or equal to 2.5 mg/dL when increase is clearly documented as due to Gilbert’s syndrome.
- Adequate renal function, with serum creatinine less than or equal to 1.5 x ULN or MDRD greater than or equal to 60 mL/min (CKD EPI Creatinine Equation).
- CNS metastases that have been treated by complete resectionsurgical removal of tissue or part/all of an organ and/or radiotherapy demonstrating stability or improvement may be enrolled provided they are stable as shown by CT/MRI scan at least 4 weeks before screening without evidence of cerebral oedemaswelling in parts of the body caused by a buildup of fluid, also known as fluid retention.
- Patients with CNS metastases requiring corticosteroidsa type of anti-inflammatory medication that is used to treat inflammation or anticonvulsants must be on a stable or declining dosethe amount of medication taken for a minimum of 10 days prior to cycle 1 day 1.
- Patients with leptomeningeal disease may be allowed in the study in agreement with sponsor and medical monitorto check on, keep track of.