Trial details
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
To find out more about this trial and your cancer treatment options, please speak with your doctor.
Trial short name: SOLIS
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
Principal Investigator: Dr. Michael Raphael
Cancer type: Gastrointestinal
Cancer location: Gastrointestinal
Disease stage: Early Cancer
Trial phase: Phase 2
Intervention: AZD0171 Durvalumab (MEDI4736)a
Registration #:
Trial description:
This is a Phase II, open-label, single arm, multicentre study of AZD0171 in combination with
durvalumab (IMFINZI®) as an addition to standard of care chemotherapy (gemcitabine and
nab-paclitaxel) in participants with 1L mPDAC. The term “study intervention” throughout the
CSP, refers to study treatment/drug (AZD0171, durvalumab, or standard of care
chemotherapy). The term “Investigational product” where used refers to AZD0171 and/or
durvalumab.
Inclusion Criteria • Participant must be aged ≥ 18 years • ECOG performance status of 0 or 1 • Must have a Gustave Roussy Immune Score (GRIm-Score) of 0 or 1 • Participants diagnosed with histologically confirmed metastatic pancreatic adenocarcinoma. • Body weight ≥ 35 kg Exclusion Criteria • 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. • History of solid organ transplantation • History of active primary immunodeficiency • A participant with an already known BRCA mutation for pancreatic cancer • Symptomatic CNS metastasis or any history of leptomeningeal disease or cord compression
