A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm

Patients must have documented recurrent or refractory solid tumors; patients enrolled in the
dose-expansion part of the trial must have least one lesion that may qualify as a target
lesion based on the RECIST 1.1 criteria. Following the provision of signed informed consent,
patients will be screened for entry into the study. Screening numbers will be assigned by the
site. Patients who do not meet entry criteria will not have their screening data entered into
the database.

Inclusion Criteria:

- Patients must have histological or cytological evidence of a solid neoplasm

- Patients enrolled in the expansion cohort must have at least one measureable lesion as
defined by the RECIST 1.1 criteria

- Patients must:

- have metastatic or unresectable advanced solid tumors that have recurred or
progressed following standard therapy or

- no longer be candidates for standard therapy or

- have tumors for which there is no standard therapy

- Patients must be ambulatory and have an ECOG Performance Score of 0 or 1;

- Patients or their legal representative must be able to provide written informed
consent;

- Patients must have adequate bone marrow reserve as evidenced by:

- White Blood Cell Count (WBC) > 3,000/µL

- Absolute Neutrophil Count (ANC) > 1,500/µL

- Platelet count (PLT) > 75,000/µL

- Hemoglobin (HGB) > 8.0 gm/dL (patients may be transfused to achieve this HGB
level);

- Patients must have adequate hepatic function as evidenced by:

- Serum AST/ALT < 3X the upper limit of normal (ULN) for the reference lab (< 5X
the ULN for patients with known hepatic metastases)

- Serum bilirubin < 1.5 x the ULN for the reference lab;

Exclusion Criteria:

- Patients with active infection or with a fever > 38.50 C within 3 days of the first
scheduled day of dosing;

- Patients with primary CNS tumors or symptomatic CNS metastases who have not undergone
surgery and/or radiotherapy and/or who are not neurologically stable;

- Patients with known hypersensitivity to any of the components of CBL0137;

- Patients who are receiving concurrent investigational therapy;

- Males with mean QTcF values of > 450 msec and females with QTcF values of > 470 msec
following 3 ECGs conducted 5 minutes apart from each other; patients who are known to
have congenital prolonged QT syndromes; or patients who are on medications known to
cause prolonged QT intervals on ECG;

Please speak with the PI for the complete Inclusion/Exclusion listing.