Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Subjects With Advanced/Relapsed Solid Tumors

This is a Phase I, open-label, multi-center trial designed to evaluate the safety,
tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with
advanced/relapsed solid tumors. The following dosing schedule, consisting of 21-day treatment
cycles, is being examined:

Five days on/two days off on Days 1 to 5, 8 to 12, and 15 to 19 (5/2 schedule).

Inclusion Criteria:

1. Subjects ≥18 years of age for solid tumor; in the case of midline carcinoma with NUT
rearrangement. subjects may be ≥16 years of age.

2. Histopathologically confirmed diagnosis of an advanced solid tumor such as breast
cancer or midline carcinoma with NUT rearrangement, that has progressed despite
standard therapy, or for which no standard therapy exists. For enrollment in the
expansion cohorts, histopathological confirmation of triple-negative breast cancer or
high-grade serous ovarian cancer is required.

3. Measurable or evaluable disease.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

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

Exclusion Criteria:

1. Systemic anticancer therapy within three weeks of study entry, except for nitrosoureas
or mitomycin C within six weeks.

2. Radiotherapy within one week prior to starting study treatment.

3. Other investigational agent(s) within 21 days prior starting to study treatment.

4. Symptomatic central nervous system (CNS) involvement or lymphangitic metastasis.
Stable or improving CNS disease that is not under active treatment after receipt of
adequate therapy is allowed.

5. Uncontrolled or severe cardiovascular disease, including myocardial infarction or
unstable angina within six months prior to study treatment, New York Heart Association
(NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring
medication for treatment, clinically significant pericardial disease or cardiac
amyloidosis.