StrataPATH™ (Precision Indications for Approved Therapies)

Inclusion Criteria

• •To be eligible to participate in this study, an individual must meet each of the criterion below and the criteria indicated in the selected biomarker/drug cohort appendix:
• •1. Male or female ≥18 years of age.
• •2. Pathologically confirmed solid tumor
• •3. Participants must be able to follow study visit schedule and willing to provide up to 20 mL of peripheral blood samples at the indicated time points
• •4. CGP results need to be from a test conducted in a CLIA approved laboratory and archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue is required for confirmatory testing of non-Strata test results unless otherwise indicated within the cohort-specific protocol criteria.
• •5. Biomarker positive for the defined cohort
• •6. For individuals with non-primary, treated or stable brain metastases: No evidence of progression (defined as no radiographic evidence of progression) for at least 4 weeks prior to consent.
• •7. Adequate bone marrow, organ function \& laboratory parameters as determined by the treating physician unless otherwise indicated within the cohort-specific protocol criteria.
• •8. Adequate cardiac function: 1) Left ventricular ejection fraction (LVEF) ≥ 50% and 2) QTc interval ≤ 470 ms (females) or ≤ 450 ms (males) average preferred.
• •An individual who meets any of the following criteria will be excluded from participation in this study:
• •1. Receiving another cancer treatment
• •2. Major surgery within 4 weeks prior to study entry
• •3. Has received a systemic cancer treatment within 3 weeks of first study dose
• •5. Participant has primary central nervous system tumor.
• •6. A woman of childbearing potential who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• •7. Females who are pregnant or nursing or plan to become pregnant or anyone unwilling to use contraception for the duration of treatment.
• •8. Ongoing toxicity of CTCAE grade \>2, other than peripheral neuropathy, related to anticancer therapy that was completed within 4 weeks of consent.
• •9. Ongoing peripheral neuropathy of CTCAE grade \>3.
• •10. History of stroke including transient ischemic attack (TIA) or acute myocardial infarction within 6 months of consent.
• •11. Participant has a known history of human immunodeficiency virus (HIV), Hepatitis B or known active Hepatitis C virus infection.
• •12. Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder.
• •13. Any other clinically significant medical condition that, in the opinion of the treating physician, makes participation undesirable, including but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness.