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

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; Pancreatic ductal adenocarcinoma; MedDRA version: 21.0Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864

• Registration Number: EUCTR2021-002040-78-ES
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-25
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 115

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 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

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. For Coronavirus disease 2019 (COVID-19) infections, a negative polymerase chain reaction test 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified