Summary

Eligibility
for people ages 18-130 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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).

Official Title

A Phase II Study to Evaluate the Safety, Pharmacokinetics, and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumours

Details

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.

Keywords

Locally Advanced or Metastatic Solid Tumours AZD0171 Durvalumab Gemcitabine Nab-paclitaxel Leukaemia inhibitory factor Pancreatic ductal adenocarcinoma Immunotherapy Neoplasms Paclitaxel AZD0171 + Durvalumab + chemotherapy

Eligibility

You can join if…

Open to people ages 18-130

  • 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

You CAN'T join 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. 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)

Locations

  • Research Site not yet accepting patients
    Los Angeles California 90025 United States
  • Research Site not yet accepting patients
    La Jolla California 92037 United States
  • Research Site not yet accepting patients
    Orange California 92868 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT04999969
Phase
Phase 2 Solid Tumor Research Study
Study Type
Interventional
Participants
Expecting 115 study participants
Last Updated