Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Prior treatment

• Previously treated for locally advanced, unresectable PDAC.
• Prior treatment with a CD73 antagonist or inhibitor.

Other illness

• History of brain metastases or leptomeningeal metastases.
• Underlying medical conditions that, in the investigator or sponsor's opinion, will make the administration of study-specified therapy hazardous
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

• Have histologically or cytologically confirmed PDAC that is metastatic.
• Have not been previously treated for PDAC in the metastatic setting.
  • Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization.
  • Prior palliative radiotherapy is allowed if completed at least 2 weeks prior to randomization and AEs have resolved to Grade 1 or less before randomization.
  • Prior and/or placement of a biliary stent/tube is permitted if any treatment-related AEs have improved to Grade ≤ 1 and the patient is not exhibiting any signs/symptoms of biliary obstruction.
• Eastern Cooperative Oncology Group PS of 0 to 1.
• At least 1 target lesion measurable by computed tomography (CT)/magnetic resonance imaging (MRI) per RECIST v1.1. not within a field of prior radiation therapy.