Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors

Study Part 1: This is a dose optimization phase designed to find a tolerated regimen that
includes identifying the MTD of itacitinib (INCB039110) (within a defined pharmacologic
range) in combination with doses of gemcitabine and nab-paclitaxel that have established
safety and tolerability in subjects with advanced or metastatic solid tumors.

Study Part 2 and Part 2A: This phase will explore the safety and tolerability of the MTD or
PAD of itacitinib (INCB039110) when administered in combination with gemcitabine and
nab-paclitaxel in subjects with untreated advanced or metastatic pancreatic cancer.

Inclusion Criteria:

- Histologically or cytologically confirmed solid tumor (Part 1) or pancreatic
adenocarcinoma (Part 2)

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

- Received no more than 1 prior chemotherapy regimen for advanced or metastatic disease
(not including neo-adjuvant and/or adjuvant therapy) (Part 1)

- Received no prior chemotherapy for advanced or metastatic disease (Part 2 and Part 2a)

- Adequate renal, hepatic, and bone marrow function without frequent blood product or
hematopoietic growth factor support (eg use of erythropoietin or transfusions > 2
units packed red blood cells every 3 months)

- Ability to swallow and retain oral medication

Exclusion Criteria:

- Any known contraindications to the use of a required comedication (gemcitabine or
nab-paclitaxel).

- Evidence of uncontrolled brain metastases or history of uncontrolled seizures.

- Ongoing radiation therapy and/or radiation therapy administered within 28 days of
enrollment or ongoing radiotherapy-related toxicities.

- Presence of ≥ Grade 2 neuropathy.

- Inability to swallow food or any condition of the upper GI tract that precludes
administration of oral medications.

- Recent (≤ 3 months) history of partial or complete bowel obstruction.

- Unwillingness to be transfused with blood components.

- Known history of Hepatitis B or C infection or HIV infection