A Phase 1 Study Evaluating CPI-0610 in Patients With Progressive Lymphoma

Inclusion Criteria:

- Adults (aged ≥ 18 years)

- Histologically confirmed diagnosis of a non-Hodgkin or Hodgkin lymphoma that has
progressed in spite of prior treatment, and for which additional effective standard
therapy is not available

- Patients may have either measurable or non-measurable disease, but in all cases
eligible patients must have disease that can be clinically evaluated for improvement
or progression

- Eastern Cooperative Oncology Group (ECOG) performance status ≤2

- Adequate hematological, renal, hepatic, and coagulation laboratory assessments

- Written informed consent to participate in this study before the performance of any
study-related procedure

Exclusion Criteria:

- A primary lymphoma of the central nervous system (CNS) or known lymphomatous
involvement of the CNS. CNS imaging and cerebrospinal fluid sampling are not
mandatory in the absence of a clinical suspicion of lymphomatous involvement of the
CNS.

- Current infection with HIV, Hepatitis B or Hepatitis C. Patients will have serologic
testing performed during screening for HIV and Hepatitis B and C. Any serologic
results suggestive of an ongoing viral infection will be further investigated as
necessary to clarify the patient's status.

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of CPI-0610, including any unresolved nausea, vomiting, or
diarrhea that is CTCAE grade >1.

- Impaired cardiac function or clinically significant cardiac diseases, including any
of the following:

- Acute myocardial infarction or angina pectoris ≤ 6 months prior to starting
study drug

- Serum cardiac troponin (cTn) level ≥ 99% percentile of the upper reference limit

- QTcF > 470 msec on the screening ECG

- Left ventricular ejection fraction (LVEF) < 40%

- Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation
are not excluded.)

- Any other concurrent severe and/or uncontrolled concomitant medical condition that
could compromise participation in the study (e.g., clinically significant pulmonary
disease, clinically significant neurological disorder, active or uncontrolled
infection)

- Systemic anti-cancer treatment or radiotherapy less than 2 weeks before the first
dose of CPI-0610

- Radioimmunotherapy (e.g., 131I-tositumomab, 90Y-ibritumomab tiuxetan) less than 6
weeks before the first dose of CPI-0610

- Treatment with an investigational small molecule less than 2 weeks before the first
dose of CPI-0610. In addition, the first dose of CPI-0610 should not occur before a
period equal to or greater than 5 half-lives of the small molecule investigational
agent has elapsed.

- Treatment with a therapeutic antibody less than 4 weeks before the first dose of
CPI-0610. A minimum 2-week period between the last treatment with a therapeutic
antibody and the first dose of CPI-0610 may be permitted in patients with rapidly
progressive or aggressive subtypes of lymphoma following discussion with the medical
monitor.

- Treatment with medications that are known to be strong inhibitors or inducers of
CYP450 enzymes.

- Treatment with medications that are known to carry a risk of Torsades de Pointes.

- Immunosuppressive treatment that cannot be discontinued both prior to study entry and
for the duration of the study. Oral prednisone at a dose of 10 mg or less per day is
allowed, as are other oral corticosteroids given at glucocorticoid-equivalent doses.
Topical, nasal and inhaled corticosteroids are also allowed.

- Pregnant or lactating women

- Women of child-bearing potential and men with reproductive potential, if they are
unwilling to use adequate contraception while on study therapy and for 3 months
thereafter

- Patients unwilling or unable to comply with this study protocol