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

• Status: Not yet recruiting
• Trial end date: 2024-02-16
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Durvalumab; Gemcitabine; Paclitaxel

Criteria

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

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)