Trial: Study of Quemliclustat and Chemotherapy…

Trial Details

Sponsor: Arcus Biosciences, Inc. (industry)

Phase: 3

Start date: Dec. 13, 2024

Planned enrollment: 610

Trial ID: NCT06608927

More trial details at ClinicalTrials.gov

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Investigational Drug AI Analysis

Show for: Quemliclustat (AB680)

HealthScout AI Analysis

Goal: Compare overall survival of quemliclustat plus nab-paclitaxel and gemcitabine versus placebo plus nab-paclitaxel and gemcitabine in previously untreated metastatic pancreatic ductal adenocarcinoma.

Patients: Adults with histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma, treatment-naive in the metastatic setting, ECOG 0–1, with at least one measurable lesion per RECIST v1.1 outside prior radiation fields. Prior neoadjuvant/adjuvant therapy allowed if completed ≥12 months before randomization; prior palliative radiotherapy allowed if completed ≥2 weeks with recovery to grade ≤1; biliary stents permitted if no active obstruction. Key exclusions include prior therapy for locally advanced unresectable PDAC, brain or leptomeningeal metastases, prior CD73 inhibitor exposure, and clinically significant comorbidities that increase risk with study therapy.

Design: Randomized, double-blind, placebo-controlled, multicenter phase 3 trial with parallel arms and allocation to investigational combination versus placebo control on a gemcitabine/nab-paclitaxel backbone.

Treatments: Experimental arm: quemliclustat plus nab-paclitaxel and gemcitabine, all given intravenously. Control arm: placebo plus nab-paclitaxel and gemcitabine, intravenously. Quemliclustat (AB680) is a potent, selective small-molecule inhibitor of CD73, targeting adenosine production in the tumor microenvironment to mitigate immunosuppression and potentially restore anti-tumor immune responses. Early-phase data (ARC-8, phase 1b) in first-line metastatic pancreatic cancer combining quemliclustat with gemcitabine/nab-paclitaxel, with or without PD-1 blockade, showed a median overall survival of 15.7 months and an objective response rate of 39%, with a manageable safety profile largely consistent with chemotherapy-related toxicities (notably neutropenia and anemia).

Outcomes: Primary: overall survival. Key secondary endpoints include progression-free survival, objective response rate, duration of response, disease control rate per RECIST v1.1, and incidence and severity of adverse events and serious adverse events. Follow-up for efficacy and safety is planned for up to 72 months.

Burden on patient: Moderate. As a double-blind phase 3 study on a standard gemcitabine/nab-paclitaxel schedule, visit frequency and imaging assessments are similar to current first-line care, with regular IV infusions and periodic CT/MRI per RECIST. Added burden stems from the additional investigational/placebo infusion and study-specific safety monitoring, which may include more frequent laboratory evaluations and adverse event assessments, but no intensive pharmacokinetic sampling or mandatory research biopsies are indicated. Travel and time commitments align with typical chemotherapy regimens, with infusion days on a weekly schedule within 28-day cycles early in treatment and routine follow-up thereafter.

Eligibility

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Sites (136)

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Wollongong Hospital

Wollongong, Australia

No email / No phone

Status: Recruiting

Oncology West - Murdoch

Murdoch, Australia

No email / No phone

Status: Recruiting

Monash Health

Clayton, Australia

No email / No phone

Status: Recruiting

Chris O'Brien Lifehouse

Camperdown, Australia

No email / No phone

Status: Recruiting

Salzburg Cancer Research Institute

Salzburg, Austria

No email / No phone

Status: Recruiting

Universitätsklinikum Sankt Pölten

Sankt Pölten, Austria

No email / No phone

Status: Recruiting

Krankenhaus Der Barmherzigen Brüder Wien

Vienna, Austria

No email / No phone

Status: Recruiting

Medizinische Universität Wien

Vienna, Austria

No email / No phone

Status: Recruiting

Institut Jules Bordet

Anderlecht, Belgium

No email / No phone

Status: Recruiting

Imeldaziekenhuis

Bonheiden, Belgium

No email / No phone

Status: Recruiting

Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

Kortrijk, Belgium

No email / No phone

Status: Recruiting

Ottawa Hospital - General Campus

Ottawa, Canada

No email / No phone

Status: Recruiting

Hôtel-Dieu de Sherbrooke

Sherbrooke, Canada

No email / No phone

Status: Recruiting

Princess Margaret Cancer Centre

Toronto, Canada

No email / No phone

Status: Recruiting

Sunnybrook Health Sciences Centre - Bayview Campus

Toronto, Canada

No email / No phone

Status: Recruiting

Fakultni Nemocnice Brno

Brno, Czechia

No email / No phone

Status: Recruiting

Nemocnice AGEL Nový Jičín a.s.

Nový Jičín, Czechia

No email / No phone

Status: Recruiting

Fakultni nemocnice v Motole

Prague, Czechia

No email / No phone

Status: Recruiting

Centre Georges François Leclerc

Dijon, France

No email / No phone

Status: Recruiting

Hôpital Huriez

Lille, France

No email / No phone

Status: Recruiting

Centre Léon Bérard

Lyon, France

No email / No phone

Status: Recruiting

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

No email / No phone

Status: Recruiting

Gustave Roussy

Villejuif, France

No email / No phone

Status: Recruiting

Katholisches Klinikum Bochum - St. Josef-Hospital

Bochum, Germany

No email / No phone

Status: Recruiting

Universitätsklinikum Würzburg

Würzburg, Germany

No email / No phone

Status: Recruiting

Universitätsklinikum Ulm

Ulm, Germany

No email / No phone

Status: Recruiting

Elblandklinikum Riesa

Riesa, Germany

No email / No phone

Status: Not yet recruiting

Otto-von-Guericke Universität

Magdeburg, Germany

No email / No phone

Status: Recruiting

SLK-Kliniken Heilbronn - Klinikum am Gesundbrunnen

Heilbronn, Germany

No email / No phone

Status: Recruiting

Medizinische Hochschule Hannover

Hanover, Germany

No email / No phone

Status: Recruiting

Katholisches Marienkrankenhaus

Hamburg, Germany

No email / No phone

Status: Recruiting

Facharztzentrum Eppendorf

Hamburg, Germany

No email / No phone

Status: Not yet recruiting

Asklepios Klinik Altona

Hamburg, Germany

No email / No phone

Status: Not yet recruiting

Krankenhaus Nordwest

Frankfurt am Main, Germany

No email / No phone

Status: Recruiting

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, Germany

No email / No phone

Status: Not yet recruiting

Azienda Ospedaliero - Universitaria Careggi

Florence, Italy

No email / No phone

Status: Recruiting

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, Italy

No email / No phone

Status: Recruiting

Ospedale di Cremona

Cremona, Italy

No email / No phone

Status: Recruiting

Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi

Bologna, Italy

No email / No phone

Status: Recruiting

Istituto Europeo di Oncologia

Milan, Italy

No email / No phone

Status: Recruiting

Azienda Ospedaliero - Universitaria di Modena

Modena, Italy

No email / No phone

Status: Not yet recruiting

Istituto Oncologico Veneto - IRCCS

Padua, Italy

No email / No phone

Status: Recruiting

Ospedale Guglielmo da Saliceto

Piacenza, Italy

No email / No phone

Status: Recruiting

IRCCS Istituto Nazionale Tumori Regina Elena

Roma, Italy

No email / No phone

Status: Recruiting

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas

Rozzano, Italy

No email / No phone

Status: Recruiting

Azienda Ospedaliero Universitaria Delle Marche

Torrette, Italy

No email / No phone

Status: Recruiting

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

No email / No phone

Status: Recruiting