Study on AZD4360 for Adults with Advanced Solid Tumors

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT06921928

This clinical trial is testing a new drug, AZD4360, to see if it is safe and effective for adults with advanced solid tumors that express a specific protein called CLDN18.2.

Patient Parameters

Program Overview

The aim of this study is to evaluate the safety and effectiveness of a new drug, AZD4360, in adults with advanced or metastatic solid tumors. Researchers will look at how the drug is processed in the body, its effects on the immune system, and its ability to shrink tumors. Participants must have tumors that express the CLDN18.2 protein.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be in good general health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have a life expectancy of at least 12 weeks.
  • Must have adequate organ and bone marrow function.
  • Must use contraception as required by local regulations.
  • Must have a confirmed diagnosis of advanced or metastatic pancreatic, gastric, gastroesophageal junction, or biliary tract cancer with positive CLDN18.2 expression.
  • Must have received at least one prior treatment for advanced or metastatic cancer.
  • Must have at least one tumor that can be measured by scans.

Exclusion Criteria

  • Cannot have HER2 positive gastric or gastroesophageal junction cancer.
  • Cannot have active or unstable peptic ulcers or significant digestive tract bleeding.
  • Cannot have significant fluid buildup in the abdomen that needs drainage.
  • Cannot have cancer that has spread to the brain or other central nervous system issues.
  • Cannot have spinal cord compression or be at high risk of paralysis.
  • Cannot have a history of lung diseases like pneumonitis.
  • Cannot have serious heart problems.
  • Cannot have had another primary cancer within the last 2 years.
  • Cannot have active hepatitis B or C.
  • Cannot have uncontrolled HIV infection.
  • Cannot have active tuberculosis.

Locations

FACILITYZIPCITYSTATE
Research Site90095Los AngelesCalifornia
Research Site02906ProvidenceRhode Island
Research Site77030HoustonTexas

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