Study to Assess the Safety, Tolerability and Pharmacokinetics of Fimepinostat (CUDC-907) in Patients With Lymphoma

Inclusion Criteria:

Subjects of ≥ 18 years of age with any of the following:

For Dose-Escalation cohorts:

- Fimepinostat + venetoclax: Histopathologically confirmed DLBCL or HGBL that is
refractory to, or has relapsed after, treatment with at least 1 prior regimen

- Fimepinostat + rituximab + bendamustine: Histopathologically confirmed diagnosis of
lymphoma (i.e., B-cell non-Hodgkin lymphoma [NHL], TCL, or HL) that is refractory to,
or has relapsed after, treatment with at least 1 prior regimen.

For Dose-Expansion cohorts:

- Fimepinostat + venetoclax: R/R DLBCL or HGBL with both MYC and BCL2 alterations and/or
overexpression (DHL, THL, or DEL) that is refractory to, or has relapsed after, 1 or
more prior lines of therapy.

- Fimepinostat + rituximab + bendamustine: R/R DLBCL or HGBL that is refractory to, or
has relapsed after, 1 or more prior lines of therapy

- Measurable disease by CT or PET/CT. MRI acceptable as per protocol.• Eastern
Cooperative Oncology Group (ECOG) performance status of 0 to 1.

- Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments
(excluding alopecia).

- Absolute neutrophil count ≥ 1,000/µL; platelets ≥ 75,000/µL for patients with no bone
marrow involvement by malignancy; platelets ≥ 50,000/µL for patients with bone marrow
involvement by malignancy.

- Creatinine ≤ 1.5x upper limit of normal (ULN); total bilirubin ≤ 1.5x ULN; AST/ALT ≤
2.5x ULN.

- Life expectancy of at least 3 months.

Exclusion Criteria:

- Intention to undergo stem cell transplant or treatment with chimeric antigen receptor
(CAR) T-cell therapy.

- Systemic anti-cancer therapy or investigational agent within 3 weeks of study entry,
except for nitrosoureas or mitomycin C (6 weeks).

- Other non-cytotoxic anti-cancer therapy or investigational agent within 5 half-lives
or 21 days prior to study treatment, whichever is shorter, as long as any drug related
toxicities have resolved to Grade 1 or less. Dexamethasone up to 12 mg/d is allowed as
supportive therapy and does not exclude participation.

- Graft vs. host disease following prior allogeneic transplant within 3 months prior to
study treatment.

- Ongoing treatment with chronic immunosuppressants.

- Active CNS lymphoma.

- Known gastrointestinal condition that would interfere with swallowing or the oral
absorption or tolerance of fimepinostat.

- Serious infection requiring systemic antibiotic therapy within 14 days prior to study
treatment.

- Uncontrolled or severe cardiovascular disease

- Unstable or clinically significant concurrent medical condition.

- Second primary malignancy within 2 years of study entry other than what is specified
in the protocol.

- Known HIV positive, hepatitis B surface antigen-positive status, or known or suspected
active hepatitis C infection.

- Active CMV infection, presence of CMV antigenemia, or evidence of any invasive CMV end
organ disease (e.g., CMV colitis).