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

Launched by ARCUS BIOSCIENCES, INC. · Sep 20, 2024

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ClinConnect Summary

This clinical trial is studying a new treatment called quemliclustat combined with chemotherapy to see if it helps patients with metastatic pancreatic ductal adenocarcinoma (PDAC) live longer compared to a placebo (a substance with no active treatment) combined with the same chemotherapy drugs. The chemotherapy used in this study includes nab-paclitaxel and gemcitabine. The trial is currently recruiting participants aged 65 to 74 who have been diagnosed with metastatic PDAC and have not received treatment for it yet.

To be eligible for this trial, participants must have confirmed metastatic PDAC and at least one measurable tumor that can be seen on scans. They should not have had prior treatment for this advanced stage, though some previous therapies are allowed if enough time has passed. Participants can expect to receive either the new treatment with quemliclustat or a placebo along with standard chemotherapy. It's important to know that there are specific health requirements that must be met to join, and individuals with certain medical histories may not be eligible. This study aims to provide insights into new potential treatments for this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have histologically or cytologically confirmed PDAC that is metastatic.
• • Have not been previously treated for PDAC in the metastatic setting.
• • 1. Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization.
• • 2. 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.
• • 3. 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.
• Exclusion Criteria:
• • 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.