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

Official record

Identifier

NCT06608927

Recruiting locations

countries

United StatesAustraliaAustriaBelgiumCanadaCzechiaFranceGermanyItalyJapanSouth KoreaSpainUnited Kingdom

Interventions studied

QuemliclustatPlaceboNab-paclitaxelGemcitabine

Lead sponsor

Arcus Biosciences, Inc.

Target enrolment

610 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Active, not recruiting

First posted

Sep 23, 2024

Last updated on the registry

Jul 31, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.