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

NCT04999969 | Active Not Recruiting Phase 2 Results FDA Drug

• 2 other identifiers: D8151C000012021-002040-78
• Study Type: interventional
• Target: 126
• Locations: 4 countries
• Sites: 34

Brief 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).

Conditions

Locally Advanced or Metastatic Solid Tumours

Keywords

AZD0171; Durvalumab; Gemcitabine; Nab-paclitaxel; Leukaemia inhibitory factor; Pancreatic ductal adenocarcinoma; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs), Immune Mediated AEs (imAEs) and Serious AEs (SAEs)

  The safety and tolerability of study intervention (AZD0171, durvalumab, and standard-of-care chemotherapy) was assessed. The grading scales found in the revised National Cancer Institute CTCAE latest version was utilized for all events with an assigned CTCAE grading. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL); Grade 4: Life-threatening, urgent intervention required; Grade 5: Death related to AE.

  From Cycle 1 Day 1 (each cycle was 28 days in length) until Day 90 (post last dose of study intervention), up to 34 months

• Overall Survival at 12 Months (OS-12)

  Percentage of participants alive at 12 months after initiation of study intervention per Kaplan- Meier estimate of OS at 12 months.

  At 12 months

Secondary Outcomes (22)

• Objective Response Rate (ORR)

  From Cycle 1 Day 1 (each cycle was 28 days in length) until initiation of subsequent anti-cancer treatment and prior to progression (up to 35 months).

• Disease Control Rate (DCR)

  Up to 16 weeks

• Duration of Response (DoR)

  From screening until disease progression or last evaluable assessment in the absence of progression, whichever came first (up to 35 months)

• Median Progression Free Survival (PFS)

  From first dose of study intervention until disease progression or last evaluable assessment in the absence of progression, whichever came first (up to 35 months)

• Progression Free Survival at 4 Months (PFS-4)

  At 4 months

Study Arms (1)

AZD0171 + Durvalumab + chemotherapy

EXPERIMENTAL

Participants will receive AZD0171 (intravenous \[IV\]) along with durvalumab (IV) in combination with standard-of-care chemotherapy IV (gemcitabine and nab-paclitaxel).

Drug: AZD0171; Drug: Durvalumab; Drug: Gemcitabine; Drug: Nab-paclitaxel

Interventions

AZD0171 DRUG

AZD0171

Also known as: MSC-1

AZD0171 + Durvalumab + chemotherapy

Durvalumab DRUG

Durvalumab

Also known as: MEDI4736

AZD0171 + Durvalumab + chemotherapy

Gemcitabine DRUG

Chemotherapy (Standard-of-Care)

AZD0171 + Durvalumab + chemotherapy

Nab-paclitaxel DRUG

Chemotherapy (Standard-of-Care)

AZD0171 + Durvalumab + chemotherapy

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (34)

Research Site

La Jolla, California, 92037, United States

Location

Research Site

Los Angeles, California, 90025, United States

Location

Research Site

Orange, California, 92868, United States

Location

Research Site

Ventura, California, 93003, United States

Location

Research Site

Atlanta, Georgia, 30318, United States

Location

Research Site

Coeur d'Alene, Idaho, 83814, United States

Location

Research Site

Boston, Massachusetts, 02114, United States

Location

Research Site

Ann Arbor, Michigan, 48109, United States

Location

Research Site

Grand Rapids, Michigan, 49503, United States

Location

Research Site

Buffalo, New York, 14263, United States

Location

Research Site

New York, New York, 10065, United States

Location

Research Site

Portland, Oregon, 97239, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

Research Site

Charlottesville, Virginia, 22908, United States

Location

Research Site

Seattle, Washington, 98195, United States

Location

Research Site

Madison, Wisconsin, 53792, United States

Location

Research Site

Barrie, Ontario, L4M 6M2, Canada

Location

Research Site

Toronto, Ontario, M4N 3M5, Canada

Location

Research Site

Toronto, Ontario, M5G 2M9, Canada

Location

Research Site

Seongnam-si, 13620, South Korea

Location

Research Site

Seongnam-si, 463-712, South Korea

Location

Research Site

Seoul, 03080, South Korea

Location

Research Site

Seoul, 03722, South Korea

Location

Research Site

Seoul, 05505, South Korea

Location

Research Site

Seoul, 06351, South Korea

Location

Research Site

Seoul, 06591, South Korea

Location

Research Site

Badalona, 08916, Spain

Location

Research Site

Barcelona, 08035, Spain

Location

Research Site

Madrid, 28027, Spain

Location

Research Site

Madrid, 28034, Spain

Location

Research Site

Madrid, 28041, Spain

Location

Research Site

Madrid, 28050, Spain

Location

Research Site

Majadahonda, 28222, Spain

Location

Research Site

Pamplona, 31008, Spain

Location

Related Links

• Redacted CSP
• Redacted CSR Synopsis
• Redacted SAP

MeSH Terms

Interventions

durvalumab; Gemcitabine; 130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: December 10, 2021
• Primary Completion: October 7, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 30, 2026
• Results First Posted: November 26, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

KR (7); US (16); CA (3); ES (8)