Study on AZD5863 for Adults with Advanced or Metastatic Solid Tumors

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06005493

Provider View

This clinical trial is testing a new treatment called AZD5863, which is designed to target specific proteins on cancer cells, to see if it is safe and effective for patients with advanced solid tumors.

Patient Parameters

Program Overview

The purpose of this study is to find out if AZD5863, a new type of treatment that targets cancer cells, is safe and can help fight cancer in patients with advanced solid tumors. AZD5863 works by engaging the body's immune system to attack cancer cells. The study will test the treatment in two ways: given through an IV (Module 1) or as an injection under the skin (Module 2). Each method will be tested in two parts: first to find the right dose, and then to see how well it works.

Description

This study is the first time AZD5863 is being tested in humans. It is a Phase I/II study, meaning it is in the early stages of testing. The study is open-label, which means both the researchers and participants know what treatment is being given. It will take place at multiple centers and will involve two different ways of giving the treatment: intravenously (through an IV) or subcutaneously (as an injection under the skin). Each method will have two parts: Part A will focus on finding the right dose, and Part B will expand to see how well the treatment works in a larger group of patients.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of adenocarcinoma in the stomach, gastro-esophageal junction, esophagus, or pancreas.
  • Have at least one tumor that can be measured by scans.
  • Tumor cells must show positive expression of a specific protein called CLDN18.2.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 12 weeks.
  • Have adequate organ and bone marrow function based on recent tests.
  • Agree to use contraception as required by local regulations.
  • Have received at least one previous treatment for advanced or metastatic cancer.

Exclusion Criteria

  • Have unresolved side effects from previous cancer treatments that are severe (Grade 2 or higher).
  • Have experienced severe immune reactions like cytokine release syndrome (CRS) or neurotoxicity from previous treatments.
  • Have a history of certain immune system disorders like hemophagocytic lymphohistiocytosis (HLH).
  • Have active or recent autoimmune or inflammatory disorders within the past 3 years.
  • Have cancer that has spread to the brain or other central nervous system issues within the past 3 months.
  • Have active infections like HIV, hepatitis B or C, or other uncontrolled infections.
  • Have certain heart conditions as specified by the study.
  • Have had a blood clotting event in the past 3 months.
  • Require ongoing treatment with immunosuppressive drugs.
  • Are currently on blood thinners.

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