Study on Cinrebafusp Alfa with Ramucirumab and Paclitaxel for HER2-High Gastric Cancer and with Tucatinib for HER2-Low Gastric Cancer
Sponsor: Pieris Pharmaceuticals, Inc.
ClinicalTrials ID:NCT05190445
This clinical trial is testing a new treatment using cinrebafusp alfa combined with other drugs to treat gastric or gastroesophageal junction cancer. The study focuses on patients with different levels of HER2 protein in their cancer cells.
Patient Parameters
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Program Overview
This study is exploring a new treatment for gastric or gastroesophageal junction (GEJ) cancer by using cinrebafusp alfa in combination with other medications. For patients with high levels of HER2 protein, the treatment includes ramucirumab and paclitaxel. For those with low levels of HER2, the treatment includes tucatinib. The goal is to see if these combinations can effectively treat the cancer.
Description
This clinical trial involves two groups of patients with gastric or gastroesophageal junction cancer. One group includes patients with high levels of HER2 protein, who will receive cinrebafusp alfa along with ramucirumab and paclitaxel. The other group includes patients with low levels of HER2, who will receive cinrebafusp alfa with tucatinib. The study aims to determine if these combinations can help control the cancer.
Participants must meet certain health criteria, such as having adequate organ function and a specific performance status, to ensure they can safely participate in the study. The trial will monitor the safety and effectiveness of the treatments, and participants will undergo regular health checks and tests to track their progress.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- For high HER2 group: Have received no more than two prior treatments for advanced cancer, including specific chemotherapy and HER2-targeted therapy.
- For low HER2 group: Have received at least one prior treatment for advanced cancer.
- Have measurable cancer according to standard criteria.
- Have adequate organ and blood function based on specific tests.
- Women of childbearing potential must not be pregnant or breastfeeding and must use effective contraception during the study and for a specified period after.
- Men must agree to use contraception if their partners are of childbearing potential.
Exclusion Criteria
- Have a type of cancer other than gastric or gastroesophageal junction adenocarcinoma.
- Have active cancer spread to the brain or spinal cord unless stable after treatment.
- Have had certain previous treatments targeting specific cancer pathways.
- Have a history of severe allergic reactions to similar treatments.
- Have significant heart problems or uncontrolled high blood pressure.
- Have certain gastrointestinal conditions or recent severe bleeding.
- Have active infections like HIV, hepatitis B, or hepatitis C.
- Have received another investigational treatment or major surgery recently.
- Are pregnant or breastfeeding, or planning to become pregnant during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Sansum Clinic | 93105 | Santa Barbara | California |
| Maryland Oncology-Hematology | 20904 | Silver Spring | Maryland |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
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