First Human Study of AZD9793 for Advanced or Metastatic Solid Tumors
Sponsor: AstraZeneca
ClinicalTrials ID:NCT06795022
This clinical trial is testing a new treatment called AZD9793, which is designed to target and fight cancer cells in patients with advanced or metastatic solid tumors that are positive for GPC3.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if AZD9793, a new type of treatment that helps the immune system target cancer cells, is safe and effective for people with advanced or metastatic solid tumors that have a specific marker called GPC3. The trial will test different ways of giving the treatment to see which is best.
Description
This study is the first time AZD9793 is being tested in humans. It is divided into two parts: one where the treatment is given through an IV (Module 1) and another where it is given as an injection under the skin (Module 2). Each part has two phases: the first phase is to find the right dose, and the second phase is to see how well the treatment works.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a tumor that tests positive for GPC3.
- Have at least one tumor that can be measured by scans.
- Be in good general health, able to carry out normal activities or light work.
- Expected to live at least 12 more weeks.
- Have good organ and bone marrow function based on recent tests.
- Use birth control as required by local guidelines.
- Have advanced liver cancer that cannot be removed by surgery, confirmed by specific medical criteria.
- Be at a certain stage of liver cancer that is not eligible for local treatments.
- Have a specific liver function score (Child-Pugh class A).
- For Part A: Have had at least one previous standard treatment for liver cancer.
- For Part B: Have had no more than one previous treatment for advanced cancer.
Exclusion Criteria
- Have unresolved side effects from previous cancer treatments, except for certain conditions like hair loss or controlled hormone disorders.
- Have participated in another clinical trial with a new treatment in the last 21 days.
- Have had CAR-T cell therapy in the last 6 months.
- Have an allergy to AZD9793 or its ingredients.
- Need ongoing treatment with high-dose steroids or other immune-suppressing drugs.
- Have had previous treatment targeting GPC3.
- Have had cancer treatment recently, including chemotherapy or radiation.
- Have had major surgery in the last 14 days.
- Have had severe reactions to previous immune therapies.
- Have a history of certain immune system disorders.
- Have heart problems as defined by the study.
- Have had a blood clot in the last 3 months.
- Have cancer that has spread to the brain or other brain conditions recently.
- Have active infections, including HIV or uncontrolled infections.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 63110 | Saint Louis | Missouri |
| Research Site | 77030 | Houston | Texas |
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