Study on the Safety and Effectiveness of AZD7789 in Adults with Advanced or Metastatic Solid Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT04931654
This clinical trial is testing a new experimental drug, AZD7789, to see if it is safe and effective for treating adults with advanced solid tumors. The study involves two parts: testing different doses and expanding the study to more participants.
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Program Overview
This study is exploring a new treatment called AZD7789, which is a type of drug that targets specific proteins involved in cancer growth. The study is divided into two parts: Part A, which tests different doses to find the safest and most effective amount, and Part B, which expands the study to more participants to further evaluate the treatment's effects. Participants will receive the drug through an IV and will be monitored for safety and effectiveness.
Description
This is the first time AZD7789 is being tested in humans. The study is open-label, meaning both the researchers and participants know what treatment is being given. It takes place at multiple centers and involves giving the drug AZD7789 through an IV to people with advanced solid tumors. The study has two parts: Part A, which involves testing different doses to find the safest and most effective amount, and Part B, which involves expanding the study to more participants to further evaluate the treatment's effects.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- For Part A and certain groups in Part B: Must have advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation.
- For another group in Part B: Must have advanced or metastatic gastric or gastro-esophageal junction cancer that cannot be treated with surgery or radiation.
- Must have at least one tumor that can be measured by scans.
- Must provide a tumor sample for testing.
- 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.
- Women must not be pregnant and must agree to use effective contraception, and men must agree to avoid fathering children during the study.
- Must have adequate organ and bone marrow function based on recent tests.
- Additional criteria for specific groups in Part A and Part B, such as previous treatments and specific cancer markers.
Exclusion Criteria
- Cannot have certain genetic mutations or alterations for which targeted therapies are available.
- Cannot have unresolved side effects from previous treatments.
- Cannot have had severe immune-related side effects from previous immunotherapy.
- Cannot have cancer that has spread to the brain or spinal cord unless treated and stable.
- Cannot have had recent serious heart or blood vessel problems.
- Cannot have had an organ or stem cell transplant.
- Cannot have active infections like TB, HIV, or hepatitis.
- Cannot have uncontrolled health conditions like heart failure or diabetes.
- Cannot have certain autoimmune or inflammatory disorders.
- Cannot have had major surgery recently.
- Cannot have had another invasive cancer within the past two years.
- Cannot have a history of certain heart rhythm problems.
- Cannot have had previous treatment with anti-TIM-3 therapy.
- Cannot be using immunosuppressive medication recently.
- Cannot be receiving other cancer treatments concurrently.
- Cannot have had a live vaccine recently.
- Cannot have had recent lung radiation therapy.
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