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Clinical Trials in the USA / NCT04999969
Active, not recruiting Phase 2

Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours

NCT04999969 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2021-12-10
Last updated
2026-08-19

Condition(s) studied

Locally Advanced or Metastatic Solid Tumours

Investigational drug(s) / intervention(s)

AZD0171DurvalumabGemcitabineNab-paclitaxel

AZD0171: AZD0171

Durvalumab: Durvalumab

Gemcitabine: Chemotherapy (Standard-of-Care)

Nab-paclitaxel: Chemotherapy (Standard-of-Care)

Study summary

The proposed study is designed to examine the effects of AZD0171 and durvalumab in combination with standard-of-care chemotherapy in patients with pancreatic ductal adenocarcinoma (PDAC).

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * Eastern Cooperative Oncology Group performance status of 0 or 1 at screening/enrolment * Must have a Gustave Roussy Immune Score of 0 or 1 * Participants diagnosed with histologically confirmed metastatic pancreatic adenocarcinoma * Participants must have at least 1 measurable lesion to be called a target lesion according to RECIST v1.1 * All participants must consent to providing sufficient archival specimen taken during metastatic stage or fresh tumour specimens for tumoural CD8+ T cell testing for enrolment * Presence of tumoural CD8+ T cells based on a predetermined benchmarked PDAC external sample * Normal organ and bone marrow function measured within 28 days prior to first dose of study intervention * Body weight ≥ 35 kg Exclusion Criteria: * Symptomatic central nervous system metastasis or any history of leptomeningeal disease or cord compression * A participant with an already known sensitising mutation or tumour characteristic for pancreatic cancer for which there is a preferred local standard-of-care treatment * History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention * Any unresolved toxicities ≥ Grade 2 per Common Terminology Criteria for Adverse Events v5.0 from prior therapy (excluding vitiligo, alopecia, controlled diabetes) * History of solid organ transplantation * History of active primary immunodeficiency * Ongoing or an active infection, including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. A negative COVID-19 PCR test taken within 28 days of the start of the study treatment is required. * Uncontrolled intercurrent illness * Participants with prior history of myocardial infarction, transient ischemic attack, coronary bypass, or stroke within the past 3 months prior to the first dose of study intervention * Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 electrocardiograms * Active or prior documented autoimmune or inflammatory disorders * History of another primary malignancy * Receipt of any conventional or investigational anticancer therapy prior to the scheduled first dose of study intervention * Prior receipt of any immune-mediated therapy * Use of immunosuppressive medication within 14 days prior to the first dose of study intervention * Receipt of live, attenuated vaccine within 28 days prior to the first dose of study intervention (Participants can receive non-live COVID-19 vaccines, at the discretion of the Investigator)

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
Research Site La Jolla California
Research Site Los Angeles California
Research Site Orange California
Research Site Ventura California
Research Site Atlanta Georgia
Research Site Coeur d'Alene Idaho
Research Site Boston Massachusetts
Research Site Ann Arbor Michigan
Research Site Grand Rapids Michigan
Research Site Buffalo New York
Research Site New York New York
Research Site Portland Oregon
Research Site San Antonio Texas
Research Site Charlottesville Virginia
Research Site Seattle Washington
Research Site Madison Wisconsin
Research Site Barrie Ontario
Research Site Toronto Ontario
Research Site Toronto Ontario
Research Site Seongnam-si South Korea
Research Site Seongnam-si South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Seoul South Korea
Research Site Badalona Spain
Research Site Barcelona Spain
Research Site Madrid Spain
Research Site Madrid Spain
Research Site Madrid Spain
Research Site Madrid Spain
Research Site Majadahonda Spain
Research Site Pamplona Spain

On this site

📄 Imfinzi (durvalumab) drug profile →

More AstraZeneca trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04999969 on ClinicalTrials.gov ↗ ← All trials in the USA