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

Sponsor: Arcus Biosciences, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06608927

Patient View

This clinical trial evaluates overall survival in patients with metastatic pancreatic ductal adenocarcinoma, comparing quemliclustat with chemotherapy to a placebo with chemotherapy. Eligible participants must have confirmed metastatic PDAC, no prior metastatic treatment, and meet specific health criteria. Interventions include quemliclustat, placebo, nab-paclitaxel, and gemcitabine.

Patient Parameters

Program Overview

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.

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 adverse events (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 or psychiatric 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.

Get This Program In Your Inbox

You can sign up and apply your patients for this program.