A Phase 1B Study of the Safety and Tolerability of INCB039110 in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors

Inclusion Criteria:

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

- 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)

- There is no restriction on the number of prior non-myelosuppressive targeted
therapies or hormonal agents (eg, EGFR targeted therapy for lung cancer and hormonal
therapy for breast cancer or ovarian cancer); targeted and/or hormonal therapy alone
will not be considered chemotherapy for the purposes of this study.

- Adequate renal, hepatic, and bone marrow function without blood product or
hematopoietic growth factor support:

- Ability to swallow and retain oral medication

Exclusion Criteria:

- Any known contraindications to the use of 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