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

An Open-Label, Phase I Dose Escalation Trial of TH-302 in Combination With Gemcitabine and Nab-Paclitaxel in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

This is a multicenter, open-label, Phase 1, dose escalation trial to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of TH-302 in combination with gemcitabine and nab-paclitaxel in previously untreated subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma.

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