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

Running, not enrolling · Phase 2

Conditions studied: Locally Advanced or Metastatic Solid Tumours

In brief

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).

Key facts

Study ID

NCT04999969

Run by

AstraZeneca

People needed

126

Starts

2021-12-10

Expected to finish

2026-06-30

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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