Table 2 General inclusion criteria
General inclusion criteria (abbreviated) | |
|---|---|
1) Patients ≥18 years of age with a histologically proven locally advanced or metastatic malignant disease for whom no standard treatment is available or indicated. | |
2) Ability to understand and the willingness to sign a written informed consent/assent document. | |
3) ECOG performance status 0–2. | |
4) Acceptable organ function. | |
5) Measurable or evaluable disease (e.g., RECIST v1.1 for solid tumors), defined as at least one lesion that can be accurately measured in at least one dimension. Patients who have assessable disease by physical or radiographic examination but do not meet these definitions of measurable disease are eligible and will be considered to have evaluable disease. | |
6) Patients must have one of the actionable alterations listed in Table 4: ProTarget Drugs and Acceptable Molecular Alterations | |
7) For oral IMPs, patients must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome. | |
8) Women of child-bearing potential and men must agree to use highly effective contraception. |