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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Metastatic Pancreatic Ductal Adenocarcinoma

In brief

The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized patients.

Key facts

Study ID

NCT06608927

Run by

Arcus Biosciences, Inc.

People needed

610

Starts

2024-12-13

Expected to finish

2030-11-30

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Previously treated for locally advanced, unresectable PDAC.
• History of brain metastases or leptomeningeal metastases.
• Prior treatment with a CD73 antagonist or inhibitor.
• 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.

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — La Jolla, California, United States
• Research Site — Los Alamitos, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Roseville, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Arlington Heights, Illinois, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Baton Rouge, Louisiana, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Grand Rapids, Michigan, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — Hattiesburg, Mississippi, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.