Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours
NCT ID: NCT04999969
Last Updated: 2026-02-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
126 participants
INTERVENTIONAL
2021-12-10
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability and Pharmacokinetics of AZD1775 (Adavosertib) Plus MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumours
NCT02617277
Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours
NCT00475956
First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours
NCT04504669
Absorption, Metabolism, Excretion and Pharmacokinetics of a Single Dose [14C]AZD2014 Followed by a Multiple Dose Phase
NCT02640755
Phase I Study of AZD2171 co-Administered With Fixed Multiple Oral Doses of ZD1839 in Patients With Advanced Cancer
NCT00502060
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All participants will be treated until progressive disease or unacceptable toxicity or withdrawal of consent or another discontinuation criterion is met.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AZD0171 + Durvalumab + chemotherapy
Participants will receive AZD0171 (intravenous \[IV\]) along with durvalumab (IV) in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel).
AZD0171
AZD0171
Durvalumab
Durvalumab
Gemcitabine
Chemotherapy (Standard-of-Care)
Nab-paclitaxel
Chemotherapy (Standard-of-Care)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AZD0171
AZD0171
Durvalumab
Durvalumab
Gemcitabine
Chemotherapy (Standard-of-Care)
Nab-paclitaxel
Chemotherapy (Standard-of-Care)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
130 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
La Jolla, California, United States
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
Research Site
Ventura, California, United States
Research Site
Atlanta, Georgia, United States
Research Site
Coeur d'Alene, Idaho, United States
Research Site
Boston, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
Buffalo, New York, United States
Research Site
New York, New York, United States
Research Site
Portland, Oregon, United States
Research Site
San Antonio, Texas, United States
Research Site
Charlottesville, Virginia, United States
Research Site
Seattle, Washington, United States
Research Site
Madison, Wisconsin, United States
Research Site
Barrie, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
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
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021-002040-78
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D8151C00001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.