Study on the Safety and Effects of AZD0171 with Durvalumab and Chemotherapy for Advanced Solid Tumors

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT04999969

Provider View

This clinical trial is testing a new treatment combination of AZD0171, durvalumab, and chemotherapy to see if it is safe and effective for patients with advanced pancreatic cancer.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effects of combining AZD0171 and durvalumab with standard chemotherapy drugs in patients with advanced pancreatic cancer. Researchers want to see how well this combination works in shrinking tumors and how the body processes these drugs.

Description

This is a Phase II study where all participants will receive the same treatment, which includes AZD0171, durvalumab, and chemotherapy drugs gemcitabine and nab-paclitaxel. The study will take place at multiple centers and will focus on understanding the safety, effectiveness, and how the body responds to these drugs. Participants will continue treatment until their cancer progresses, they experience unacceptable side effects, or they choose to stop.

Eligibility Criteria

Inclusion Criteria

  • Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have a specific immune score of 0 or 1.
  • Diagnosed with advanced pancreatic cancer that has spread.
  • Must have at least one measurable tumor.
  • Must agree to provide a tumor sample for testing.
  • Must have a certain level of immune cells in the tumor.
  • Must have normal organ and bone marrow function based on recent tests.
  • Must weigh at least 35 kg (about 77 pounds).

Exclusion Criteria

  • Have cancer that has spread to the brain or spinal cord.
  • Have a known mutation or tumor characteristic that has a preferred treatment.
  • Have had a blood clot or similar event in the past 3 months.
  • Have unresolved side effects from previous treatments, except for certain conditions like controlled diabetes.
  • Have had an organ transplant.
  • Have a primary immune deficiency.
  • Have an active infection, including tuberculosis, hepatitis, or HIV. Must have a negative COVID-19 test before starting the study.
  • Have uncontrolled illnesses.
  • Have had a heart attack, stroke, or similar event in the past 3 months.
  • Have a specific heart rhythm issue.
  • Have an autoimmune or inflammatory disorder.
  • Have had another type of cancer.
  • Have received any cancer treatment before starting the study.
  • Have received immune therapy before.
  • Have used immunosuppressive medication recently.
  • Have received a live vaccine recently, except for non-live COVID-19 vaccines.

Locations

FACILITYZIPCITYSTATE
Research Site92037La JollaCalifornia
Research Site90025Los AngelesCalifornia
Research Site92868OrangeCalifornia
Research Site93003VenturaCalifornia
Research Site30318AtlantaGeorgia
Research Site83814Coeur d'AleneIdaho
Research Site02114BostonMassachusetts
Research Site48109Ann ArborMichigan
Research Site49503Grand RapidsMichigan
Research Site14263BuffaloNew York

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