Table 2:

Summary of major inclusion and exclusion criteria for registration^*

Inclusion Criteria

1. Patient (age ≥ 12 years**) with a histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefitting from standard anti-cancer treatment or no such treatment is available or indicated.

2. ECOG performance status 0–2 and acceptable organ function defined per protocol.

3. Patients must have measurable or evaluable disease (per RECIST v1.1 for solid tumor, Lugano criteria for non-Hodgkin lymphoma or International Myeloma Working Group criteria for multiple myeloma).

4. Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression performed in a CLIA-certified, CAP-accredited, and New York State accredited (for labs offering services to residents of NY) laboratory.

5. Have a tumor genomic profile for which treatment with one of the FDA approved targeted anti-cancer treatments included in this study has potential clinical benefit based on the genomic criteria.

6. Ability to understand and the willingness to sign a written informed consent/assent document.

Exclusion Criteria

1. Ongoing toxicity ≥ CTCAE grade 2, other than peripheral neuropathy, related to anti-tumor treatment that was completed within 4 weeks prior to registration. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.

2. Patient is receiving any other anti-cancer treatment.

3. Female patients who are pregnant or nursing. Male patients who refuse to practice barrier contraception methods.

4. Patients with primary brain tumors are excluded. Patients with known progressive brain metastases determined by serial imaging or declining neurologic function in the opinion of the treating physician are not eligible. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month prior to study enrollment.

5. Patients with preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.

6. Patients with left ventricular ejection fraction (LVEF) known to be < 40% are not eligible.

7. Patients with stroke (including TIA) or acute myocardial infarction within 4 months before the first dose of study treatment are not eligible

8. Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, severe psychiatric illness situations, or anticipated or planned anti-cancer treatment or surgery.

^*This list includes only major eligibility criteria.

^**Restrictions apply. Not all therapies are available for patients <18. Refer to Table 1.