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

  • STATUS
    Recruiting
  • End date
    Mar 20, 2024
  • participants needed
    115
  • sponsor
    AstraZeneca
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Updated on 4 October 2022
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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).

Description

This is a Phase II, open-label, single arm, multicentre study to assess the safety, preliminary antitumour activity, immunogenicity, pharmacodynamics (PD), and pharmacokinetics (PK) of AZD0171 in combination with durvalumab and standard-of-care chemotherapy (gemcitabine and nab-paclitaxel) in participants with first line (1L) metastatic pancreatic ductal adenocarcinoma (mPDAC).

All participants will be treated until progressive disease or unacceptable toxicity or withdrawal of consent or another discontinuation criterion is met.

Details
Condition Locally Advanced or Metastatic Solid Tumours
Treatment Gemcitabine, Nab-paclitaxel, durvalumab, AZD0171
Clinical Study IdentifierNCT04999969
SponsorAstraZeneca
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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)
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