Study Of Quemliclustat And Chemotherapy Versus Placebo And Chemotherapy In Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Study Overview

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

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.

N/A

Metastatic Pancreatic Ductal Adenocarcinoma

DRUG: Quemliclustat
DRUG: Placebo
DRUG: Nab-paclitaxel
DRUG: Gemcitabine

PRISM-1
2024-513317-12-00 (CTIS Identifier) (CTIS: )
jRCT2061240084 (OTHER Identifier) (OTHER: Japan Registry of Clinical Trials)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-09-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-28
First Submitted that Met QC Criteria 2024-09-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-08-29
First Posted (ESTIMATED) 2024-09-23	Results First Posted N/A	Last Verified 2024-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm A (Experimental Arm) Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion	DRUG: Quemliclustat Administered as specified in the treatment arm DRUG: Nab-paclitaxel Administered as specified in the treatment arm DRUG: Gemcitabine Administered as specified in the treatment arm
PLACEBO_COMPARATOR: Arm B (Comparator Arm) Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion	DRUG: Placebo Administered as specified in the treatment arm DRUG: Nab-paclitaxel Administered as specified in the treatment arm DRUG: Gemcitabine Administered as specified in the treatment arm

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm A (Experimental Arm)

Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion

DRUG: Quemliclustat

Administered as specified in the treatment arm

DRUG: Nab-paclitaxel

Administered as specified in the treatment arm

DRUG: Gemcitabine

Administered as specified in the treatment arm

PLACEBO_COMPARATOR: Arm B (Comparator Arm)

Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion

DRUG: Placebo

Administered as specified in the treatment arm

DRUG: Nab-paclitaxel

Administered as specified in the treatment arm

DRUG: Gemcitabine

Administered as specified in the treatment arm

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival (OS)		Up to 72 months

Secondary Outcome Measures	Measure Description	Time Frame
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
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Arcus Biosciences

Phone Number: +1-510-462-3330

Email: ClinicalTrialInquiry@arcusbio.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Have histologically or cytologically confirmed PDAC that is metastatic.
Have not been previously treated for PDAC in the metastatic setting.

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Taiho Pharmaceutical Co., Ltd.

Investigators

STUDY_DIRECTOR: Medical Director, Arcus Biosciences

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record