Ph 1 Study of VS-4718, a FAK Inhibitor, in Combination With Nab-paclitaxel and Gemcitabine in Advanced Cancer Subjects

Inclusion Criteria:

* Age ≥ 18 years
* Histologically or cytologically confirmed diagnosis of an advanced nonhematological malignancy (Part A) or advanced pancreatic adenocarcinoma (Part B) that is not surgically resectable
* Eligible for treatment with nab-paclitaxel and gemcitabine on Days 1, 8, and 15 in 28-day cycles as standard therapy
* Evaluable or measurable disease, as assessed by RECIST v1.1
* ECOG performance status of ≤ 1
* Adequate renal function (creatinine ≤ 1.5×ULN \[upper limit of normal\]) or glomerular filtration rate of ≥ 60 mL/min
* Adequate hepatic function (total bilirubin ≤ 1.5×ULN for the institution; aspartate transaminase and alanine transaminase ≤ 2.5×ULN, or ≤ 5×ULN if due to liver involvement by tumor; albumin ≥ 3 g/dL)
* Adequate bone marrow function (hemoglobin ≥ 9.0 g/dL; unsupported platelets ≥ 100×109 cells/L; absolute neutrophil count \[ANC\] ≥ 1.5×109 cells/L without the use of hematopoietic growth factors)
* Corrected QT interval (QTc) \< 470 ms
* Willing and able to participate in the trial and comply with all trial requirements

Exclusion Criteria:

* Gastrointestinal (GI) condition that could interfere with the swallowing or absorption of study medication
* Uncontrolled or severe concurrent medical condition (including uncontrolled brain metastases).
* History of upper gastrointestinal bleeding, ulceration, or perforation within 6 months prior to the first dose of protocol therapy
* Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of protocol therapy.
* Part B only: Prior therapy (including investigational agents) for pancreatic cancer
* Chemotherapy or radiotherapy within 14 days prior to first dose of protocol therapy
* Active treatment for a secondary malignancy