Full TitleMV-0916-CP-001.01: Phase I, Open-Label, Multi-Center, Dose Escalation with Expansion Trial of 177Lu Human Monoclonal Antibody 5B1 (MVT-1075) in Combination with a Blocking Dose of MVT-5873 as Radioimmunotherapy in Relapsed/Refractory Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies
The purpose of this study is to find the highest dose of the investigational drug MVT-1075 that can be used safely in patients with inoperable or advanced pancreatic cancer that has continued to grow or came back despite prior treatment. MVT-1075 is a form of “radioimmunotherapy.” It targets a protein called CA19-9 which is present in many solid tumors, including pancreatic cancer.
MVT-1075 is paired with a radioactive tracer. When MVT-1075 finds cancer cells containing CA19-9, it binds to them, allowing a high dose of radiation to be delivered directed to the tumor while minimizing radiation exposure to normal cells. MVT-1075 is given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have inoperable or metastatic pancreatic cancer that has continued to grow or came back despite at least one prior regimen of therapy.
- Patients’ tumors must be positive for CA19-9. Testing for this protein will be done to determine eligibility for this study.
- At least 4 weeks must pass between the completion of previous treatments and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Eileen O’Reilly at 646-888-4182.