Study on YH32367 for Patients with HER2 Positive Advanced or Metastatic Solid Tumors
Sponsor: Yuhan Corporation
ClinicalTrials ID:NCT05523947
This clinical trial is testing a new drug, YH32367, to see if it is safe and effective for treating patients with HER2-positive advanced or metastatic solid tumors. The study will also look at how the drug behaves in the body and its ability to fight tumors.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new drug called YH32367 in patients with HER2-positive advanced or metastatic solid tumors. YH32367 is a special type of antibody that targets specific proteins on cancer cells to help the immune system attack the tumor. The study will be conducted in two parts: the first part will determine the best dose of the drug, and the second part will confirm its safety and effectiveness at that dose.
Description
YH32367 is a new type of treatment that targets two proteins, HER2 and 4-1BB, on cancer cells. By doing this, it helps the immune system attack and destroy the cancer cells. This study is the first time YH32367 is being tested in humans. It will be conducted in two phases. The first phase will find the safest and most effective dose of the drug. The second phase will test this dose in more patients to confirm its safety and effectiveness. Participants will receive the drug and be monitored for any side effects and how well the cancer responds to the treatment.
Eligibility Criteria
Inclusion Criteria
- For the first part of the study, patients must have HER2-positive cancer confirmed by tests and provide a tumor sample.
- For the second part, patients must have at least one tumor that can be measured and provide a tumor sample.
- Cohort 1: Patients with HER2-positive biliary tract cancer.
- Cohort 2: Patients with HER2-positive metastatic solid tumors, excluding breast, gastric, or gastroesophageal junction cancers.
Exclusion Criteria
- Uncontrolled cancer spread to the brain or spinal cord.
- Spinal cord compression.
- Cancer spread to the membranes around the brain and spinal cord.
- Recent heart problems like heart attacks.
- Heart failure.
- Lung diseases like interstitial lung disease or pneumonitis.
- History of another type of cancer.
- HIV infection.
- Active hepatitis B or C infections.
- Use of systemic steroid therapy.
- Autoimmune diseases.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Vanderbilt Ingram Cancer Center | 37232 | Nashville | Tennessee |
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