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

Phase 3

Recruiting

• Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
• Interventions: Drug: Quemliclustat; Drug: Placebo; Drug: Nab-paclitaxel; Drug: Gemcitabine

• Registration Number: NCT06608927
• Lead Sponsor: Arcus Biosciences, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-23
• Study Start: 2024-12-13
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-26
• Primary Completion: 2030-11-30
• Study Completion: 2030-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 610

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B (Comparator Arm)	Nab-paclitaxel	Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion
Arm B (Comparator Arm)	Gemcitabine	Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion
Arm A (Experimental Arm)	Quemliclustat	Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion
Arm A (Experimental Arm)	Nab-paclitaxel	Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion
Arm A (Experimental Arm)	Gemcitabine	Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion
Arm B (Comparator Arm)	Placebo	Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 72 months

Secondary Outcome Measures

Name	Time	Method
Duration of response (DoR) as determined by the Investigator according to RECIST v1.1	Up to 72 months
Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1	Up to 72 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	Up to 72 months
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1	Up to 72 months
Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1	Up to 72 months

Trial Locations

Locations (97)

Mayo Clinic Arizona - Phoenix Campus; 🇺🇸 Phoenix, Arizona, United States

University of Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Cancer & Blood Specialty Clinic - Los Alamitos; 🇺🇸 Los Alamitos, California, United States

Keck Medicine of USC - Keck Hospital of USC; 🇺🇸 Los Angeles, California, United States

Sutter Medical Center; 🇺🇸 Roseville, California, United States

UCLA Health - Santa Monica Cancer Care; 🇺🇸 Santa Monica, California, United States

USOR - Rocky Mountain Cancer Centers - Denver - Midtown; 🇺🇸 Denver, Colorado, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Mayo Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Miami Cancer Institute; 🇺🇸 Miami, Florida, United States

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