Clinical trial • Phase III • Oncology

QUEMLICLUSTAT for Pancreatic ductal adenocarcinoma (PDAC) | Metastatic pancreatic ductal adenocarcinoma (mPDAC) | Pancreatic cancer

Phase III trial of QUEMLICLUSTAT for Pancreatic ductal adenocarcinoma (PDAC) | Metastatic pancreatic ductal adenocarcinoma (mPDAC) | Pancreatic cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Pancreatic ductal adenocarcinoma (PDAC) | Metastatic pancreatic ductal adenocarcinoma (mPDAC) | Pancreatic cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
20-08-2024
First CTIS Authorization Date
05-12-2024

Trial design

Randomised, arm a: quemliclustat + nab-paclitaxel and gemcitabine; arm b: placebo (saline) + nab-paclitaxel and gemcitabine. doses and schedules not specified in the provided record.-controlled Phase III trial in Austria, Belgium, Czechia and others.

Randomised
Yes
Comparator
Arm A: Quemliclustat + nab-paclitaxel and gemcitabine; Arm B: Placebo (saline) + nab-paclitaxel and gemcitabine. Doses and schedules not specified in the provided record.
Target Sample Size
352

Eligibility

Recruits 352 The record indicates vulnerable populations selected (isVulnerablePopulationSelected = true). Consent must be provided by the participant (Age ≥ 18 years or age greater than or equal to the regionally approved age of consent for participation in investigational clinical studies at the time of signing the informed consent). Language- and country-specific informed consent documents are provided (see ICF documents per country)..

Vulnerable Population
The record indicates vulnerable populations selected (isVulnerablePopulationSelected = true). Consent must be provided by the participant (Age ≥ 18 years or age greater than or equal to the regionally approved age of consent for participation in investigational clinical studies at the time of signing the informed consent). Language- and country-specific informed consent documents are provided (see ICF documents per country).

Inclusion criteria

  • {"criterion_text":"- Have histologically or cytologically confirmed PDAC that is metastatic.\n- Age ≥ 18 years (or age greater than or equal to regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent.\n- Have not been previously treated for PDAC in the metastatic setting. a. Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization. b. 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. 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.\n- Eastern Cooperative Oncology Group PS of 0 to 1 within 7 days of randomization.\n- 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

  • {"criterion_text":"- Previously treated for locally advanced, unresectable PDAC.\n- History of brain metastases or leptomeningeal metastases.\n- Prior treatment with a CD73 antagonist or inhibitor.\n- History of trauma or major surgery within 28 days prior to randomization.\n- History of ascites requiring therapeutic paracenteses or diuretics."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival is defined as the time from date of randomization until the date of death from any cause.","definition_or_measurement_approach":"Time from date of randomization until date of death from any cause (overall survival)."}

Secondary endpoints

  • {"endpoint_text":"- Progression-free survival is defined as the time from the date of randomization until disease progression or death from any cause, whichever comes first, as measured per RECIST v1.1 as assessed by the investigator.","definition_or_measurement_approach":"Time from randomization to disease progression or death (whichever comes first), assessed per RECIST v1.1 by the investigator."}
  • {"endpoint_text":"- Objective response rate (ORR) is defined as the proportion of patients who have achieved best overall response of confirmed complete response (CR) or partial response (PR) to study therapy as assessed by the investigator according to RECIST 1.1.","definition_or_measurement_approach":"Proportion of patients with confirmed CR or PR as best overall response, per RECIST v1.1 assessed by investigator."}
  • {"endpoint_text":"- Duration of response is defined as the time from the first objective response (CR or PR) until the date of first documented disease progression or death, whichever comes first, as measured per RECIST v1.1 as assessed by the investigator.","definition_or_measurement_approach":"Time from first documented objective response (CR or PR) to first documented progression or death, per RECIST v1.1 assessed by investigator."}
  • {"endpoint_text":"- Disease control rate is defined as the proportion of patients who have achieved confirmed CR, confirmed PR, or stable disease for ≥ 8 weeks from the date of randomization, as assessed by the investigator according to RECIST 1.1.","definition_or_measurement_approach":"Proportion of patients with confirmed CR, confirmed PR, or stable disease maintained ≥8 weeks from randomization, per RECIST v1.1 assessed by investigator."}
  • {"endpoint_text":"- The incidence and severity of adverse events and serious adverse events, and any clinically meaningful trends in safety parameters.","definition_or_measurement_approach":"Collection and reporting of incidence and severity (and trends) of adverse events and serious adverse events per study safety monitoring procedures."}

Recruitment

Planned Sample Size
352
Recruitment Window Months
70
Consent Approach
Informed consent must be signed by participants (Age ≥ 18 years or regionally approved age of consent). Multiple country- and language-specific subject information and informed consent form documents are provided (examples: NL, PL, ES, FR, DE/AT, IT, CZ, EN versions and pregnancy-specific and scout/privacy variants listed in the published documents list). Contact/functional sponsor contact for inquiries: Medical Director, clinicaltrialinquiry@arcusbio.com.

Geography

Total Number Of Sites
54
Total Number Of Participants
258

Austria

Earliest CTIS Part Ii Submission Date
05-12-2024
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
509
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Krankenhaus Der Barmherzigen Brueder Wien
Department Name
Internal Medicine II
Contact Person Name
Johannes Meran
Contact Person Email
johannes.meran@bbwien.at
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Medical University Hospital Salzburg, Landeskrankenhaus Medical Department III
Contact Person Name
Lukas Weiss
Contact Person Email
lu.weiss@salk.at
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
University Hospital St. Pölten – Department of Internal Medicine I
Contact Person Name
Petra Pichler
Site Name
Medical University Of Vienna
Department Name
Department of Medicine I Division of Oncology
Contact Person Name
Gerald Prager
Contact Person Email
gerald.prager@meduniwien.ac.at

Belgium

Earliest CTIS Part Ii Submission Date
21-11-2024
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
523
Number Of Sites
3
Number Of Participants
24

Sites

Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Gastroenterology
Contact Person Name
Alexander Vanden Bulcke
Site Name
Institut Jules Bordet
Department Name
Digestive Oncology
Contact Person Name
Jean-Luc Van Laethem
Site Name
Imelda
Department Name
Gastroenterology & Hepatology
Contact Person Name
Pieter Jan Cuyle
Contact Person Email
pieterjan.cuyle@imelda.be

Czechia

Earliest CTIS Part Ii Submission Date
19-11-2024
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
526
Number Of Sites
3
Number Of Participants
23

Sites

Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
Onkologická klinika
Contact Person Name
Stanislav Batko
Contact Person Email
stanislav.batko@fnmotol.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interní Hematologická a Onkologická Klinika
Contact Person Name
Zdeněk Král
Contact Person Email
kral.zdenek@fnbrno.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Komplexní onkologické centrum Oddělení radioterapie a onkologie
Contact Person Name
Lenka Teglová
Contact Person Email
lenka.teglova@nnj.agel.cz

France

Earliest CTIS Part Ii Submission Date
02-12-2024
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
518
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Institut Gustave Roussy
Department Name
DITEP Drug Development Department
Contact Person Name
Antoine Hollebecque
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Medical Oncology
Contact Person Name
Anthony Turpin
Contact Person Email
anthony.turpin@chrulille.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Gastroenterology and medical Oncology
Contact Person Name
David Tougeron
Contact Person Email
david.tougeron@chupoitiers.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Medical Oncology
Contact Person Name
François Ghiringhelli
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Philippe Cassier

Germany

Earliest CTIS Part Ii Submission Date
20-11-2024
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
530
Number Of Sites
10
Number Of Participants
50

Sites

Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Department of Gastroenterology, Hepatology and Infectious Diseases (KGHI)
Contact Person Name
Marino Venerito
Contact Person Email
m.venerito@med.ovgu.de
Site Name
Katholisches Klinikum Bochum gGmbH
Department Name
Klinikum der RuhrUniversität Bochum / St Josef Hopsital Hematology, Oncology, Palliative Care
Contact Person Name
Anke Reinacher-Schick
Contact Person Email
anke.reinacher@rub.de
Site Name
Krankenhaus Nordwest GmbH
Department Name
Upper-GastroIntestinal-tract
Contact Person Name
Thörsten Oliver Götze
Contact Person Email
Goetze.thorsten@khnw.de
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Klinik für Innere Medizin III
Contact Person Name
Uwe Martens
Contact Person Email
Uwe.martens@slk-kliniken.de
Site Name
Haematologisch Onkologische Praxis Eppendorf / Norddeutsches Studienzentrum für Innovative Onkologie
Contact Person Name
Eray Gökkurt
Contact Person Email
goekkurt@hope-hamburg.de
Site Name
ELBLANDKLINIKEN Stiftung & Co. KG
Department Name
Klinik für Innere Medizin Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Jörg Schubert
Site Name
Medizinische Hochschule Hannover
Department Name
Department of Gastroenterology, Hepatology, and Endocrinology
Contact Person Name
Thomas Wirth
Contact Person Email
wirth.thomas@mh-hannover.de
Site Name
Katholisches Marienkrankenhaus gGmbH
Department Name
Department of Internal Medicine
Contact Person Name
Gunnar Hapke
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Kilinik und Poliklinik II
Contact Person Name
Volker Kunzmann
Contact Person Email
kunzmann_v@ukw.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Department of Internal Medicine I Center for Internal Medicine
Contact Person Name
Thomas Theodor

Italy

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
598
Number Of Sites
12
Number Of Participants
40

Sites

Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Medicine/Dig estive Molecular Clinical Oncology Reserach Unit
Contact Person Name
Davide Melisi
Contact Person Email
Davide.melisi@univr.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Medical Oncology Unit
Contact Person Name
Mariacristina Di Marco
Contact Person Email
Mariacristina.dimarco@unibo.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Medical Oncology Deparment
Contact Person Name
Rossana Berardi
Site Name
Azienda Unita Sanitaria Locale Di Piacenza
Department Name
Onomatology
Contact Person Name
Elena Orlandi
Contact Person Email
e.orlandi@ausl.pc.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Department of Oncology and Hematology
Contact Person Name
Fabio Gelsomino
Contact Person Email
Gelsomino.fabio@aou.mo.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Medical Oncology of Gastrointestin al and Neuroendocrine tumours
Contact Person Name
Lorenzo Gervaso
Contact Person Email
Lorenzo.gervaso@ieo.it
Site Name
Istituto Oncologico Veneto
Department Name
Medical Oncology unit 1
Contact Person Name
Letizia Procaccio
Site Name
Careggi University Hospital
Department Name
Clinical Oncology Unit
Contact Person Name
Lorenzo Antonuzzo
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Medical Oncology Unit 2
Contact Person Name
Emanuela Dell’Aquila
Contact Person Email
Emanuela.dellaquila@ifo.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Medical Oncology and Hematology Unit
Contact Person Name
Silvia Bozzarelli
Site Name
Azienda Socio Sanitaria Territoriale Di Cremona
Department Name
Oncology unit
Contact Person Name
Giulia Grizzi
Contact Person Email
Giulia.grizzi@asst-cremona.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Medical Oncology division 1
Contact Person Name
Filippo Pietrantonio

Netherlands

Earliest CTIS Part Ii Submission Date
01-11-2024
Latest Decision Or Authorization Date
14-07-2025
Processing Time Days
255
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Medical Oncology
Contact Person Name
Johanna (Hanneke) Wilmink
Contact Person Email
j.w.wilmink@amsterdamumc.nl
Site Name
St. Antonius Ziekenhuis
Department Name
Medical Oncology
Contact Person Name
Maartje Los
Contact Person Email
m.los@antoniusziekenhuis.nl

Poland

Earliest CTIS Part Ii Submission Date
13-11-2024
Latest Decision Or Authorization Date
11-07-2025
Processing Time Days
240
Number Of Sites
3
Number Of Participants
17

Sites

Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Oddział Onkologii i Radioterapii, Onkologia Kliniczna Leczenie „Jednego Dnia”
Contact Person Name
Joanna Pikiel
Contact Person Email
joanna.pikiel@post.pl
Site Name
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name
Oddzial Onkologii Klinicznej z Pododdzialem Dziennym
Contact Person Name
Anna Kowalczyk-Tekiela
Contact Person Email
atekiela@interia.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oddział Onkologii i Radioterapii
Contact Person Name
Lucjan Wyrwicz
Contact Person Email
Lucjan.Wyrwicz@nio.gov.pl

Spain

Earliest CTIS Part Ii Submission Date
04-11-2024
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
546
Number Of Sites
12
Number Of Participants
58

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology department
Contact Person Name
Jaume Capdevila
Contact Person Email
jcapdevila@vhio.net
Site Name
Clinica Universidad De Navarra
Department Name
Oncology department
Principal Investigator Name
Mariano Ponz Sarvisé
Principal Investigator Email
mponz@unav.es
Contact Person Name
Mariano Ponz Sarvisé
Contact Person Email
mponz@unav.es
Site Name
Institut Catala D'oncologia
Department Name
Oncology Department
Contact Person Name
Adelaida Garcia Velasco
Contact Person Email
agvelasco@iconcologia.net
Site Name
Hospital Universitario De Navarra
Department Name
Oncology Department
Contact Person Name
Ruth Vera Garcia
Contact Person Email
rveragar@cfnavarra.es
Site Name
Clinica Universidad De Navarra (Madrid site)
Department Name
Oncology department
Principal Investigator Name
Mariano Ponz Sarvisé
Principal Investigator Email
mponz@unav.es
Contact Person Name
Mariano Ponz Sarvisé
Contact Person Email
mponz@unav.es
Site Name
Hospital Universitario Miguel Servet
Department Name
Oncology department
Contact Person Name
Roberto Pazo Cid
Contact Person Email
rpazo@salud.aragon.es
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology Department
Contact Person Name
Ismael Macías
Contact Person Email
imacias@clinic.cat
Site Name
Hospital Alvaro Cunqueiro
Department Name
Oncology department
Contact Person Name
Paula Gonzalez Villarroel
Site Name
Hospital General Universitario De Elche
Department Name
Oncology Department
Contact Person Name
Javier Gallego Plazas
Contact Person Email
j.gallegoplazas@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Oncology department
Contact Person Name
Jaime Feliu Batlle
Contact Person Email
jaime.feliu@uam.es
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology department
Contact Person Name
Antonio Cubillo Gracian
Contact Person Email
acubillo@hmhospitales.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology Department
Contact Person Name
Rocio Garcia Carbonero
Contact Person Email
rgcarbonero@salud.madrid.org

Sponsor

Primary sponsor

Full Name
Arcus Biosciences Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
codes: 12,13,4,5,7,8
Name
Ppd Inc.
Responsibilities
codes: 8
Name
Cytel Inc.
Responsibilities
codes: 10,6

Third parties

  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes: 12,13,4,5,7,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Aliri USA Inc.","duties_or_roles":"codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"codes: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"codes: 10,6","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"codes: 3,7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Omnitrace Corp.","duties_or_roles":"codes: 15 (Long term follow up support)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"codes: 8","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Quemliclustat
Active Substance
QUEMLICLUSTAT
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
prodAuthStatus: 1
Investigational Product Name
Gemcitabine
Active Substance
GEMCITABINE
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
prodAuthStatus: 2
Investigational Product Name
Paclitaxel albumin-bound (nab-paclitaxel)
Active Substance
PACLITAXEL ALBUMIN-BOUND
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
prodAuthStatus: 2
Investigational Product Name
Saline (placebo)
Active Substance
SALINE
Modality
Other
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
prodAuthStatus: 2
Combination Treatment
Yes

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