Study on AZD0022 for Treating Tumors with KRASG12D Mutation in Adults

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06599502

Provider View

This clinical trial is testing a new drug, AZD0022, both on its own and in combination with other cancer treatments, to see if it is safe and effective for adults with tumors that have a specific KRASG12D mutation.

Patient Parameters

Program Overview

This study is the first to test AZD0022 in humans. It aims to find out if AZD0022 is safe and how well it works when used alone or with other cancer drugs in adults with tumors that have a KRASG12D mutation. The study is being conducted at multiple centers and involves different parts to determine the best dose and effectiveness of the treatment.

Description

The study is divided into two main modules:

  • Module 1: Tests AZD0022 by itself.
  • Module 2: Tests AZD0022 with other cancer drugs, like Cetuximab.

Each module has three parts:

  • Part A: Tests different doses to find the safest amount.
  • Part B: Adjusts the dose to find the most effective amount.
  • Part C: Expands the study to see how well the treatment works.

Participants will take AZD0022 orally and will be monitored for safety, side effects, and how well the treatment works against their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of a tumor that is advanced or has spread, with a KRASG12D mutation.
  • Have tried standard treatments for their cancer type, but the cancer has not responded or has returned.
  • Have at least one tumor that can be measured by scans.
  • Provide a sample of their tumor for testing.
  • Have good organ and bone marrow function.

Module 1 Specifics:

  • For lung cancer: Must have tried at least one standard treatment.
  • For colorectal cancer: Must have tried at least two standard treatments.
  • For pancreatic cancer: Must have tried at least one standard treatment.

Module 2 Specifics:

  • For colorectal cancer: Must have tried at least two standard treatments.
  • For pancreatic cancer: Must have tried at least one standard treatment.

Exclusion Criteria

  • Have any severe or uncontrolled medical conditions.
  • Have lung disease that required high doses of steroids or oxygen.
  • Have untreated or active brain cancer, except for stable, symptom-free cases.
  • Have had an organ transplant.
  • Have heart problems, such as abnormal heart rhythms or recent heart attacks.
  • Have taken any KRAS inhibitors before.
  • Are using herbal medicines or certain other medications that affect the liver.
  • Have had recent cancer treatments, like chemotherapy or radiation, within a certain time before starting the study.

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