Phase I TH-302 Plus Gemcitabine Plus Nab-Paclitaxel in Pancreatic Cancer

Inclusion Criteria:

- Subjects greater than or equal to (>=) 18 years of age with locally advanced
unresectable or metastatic pancreatic adenocarcinoma proven by histology or cytology
and previously untreated with chemotherapy or systemic therapy other than:

- Radiosensitizing doses of 5-fluorouracil;

- Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after
completion of gemcitabine;

- Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical
resection;

- Adjuvant chemotherapy if relapse occurred at least 6 months after completion of
adjuvant chemotherapy

- Subjects may have measurable or non-measurable disease according to RECIST 1.1.

- Eastern cooperative oncology group (ECOG) performance status of 0 or 1

- Acceptable hematological status, liver and renal function as defined in the protocol

- Other protocol defined inclusion criteria could apply

Exclusion Criteria:

- Significant cardiac or peripheral vascular arterial disease

- Known brain, leptomeningeal or epidural metastases (unless treated and well controlled
for at least 3 months)

- Severe chronic obstructive or other pulmonary disease with hypoxemia

- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
therapy

- Subjects receiving concomitant treatment with radiotherapy or other investigational
drugs

- Other protocol defined exclusion criteria could apply