A PHASE 1/2 DOSE ESCALATION AND DOSE EXPANSION STUDY OF BA3011 ALONE AND IN COMBINATION WITH NIVOLUMAB IN ADULT AND ADOLESCENT PATIENTS 12 YEARS AND OLDER WITH ADVANCED SOLID TUMORS
Sponsor: |
BioAtla LLC |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAS7054 |
U.S. Govt. ID: |
NCT03425279 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
The purpose of this study is to test the safety of different doses of BA3011 and to find out what effects, good and/or bad, that it has on advanced solid tumor cancers that have tested positive for the AXL protein. AXL is a protein found on certain types of cancer cells. This research study will choose the dose amount that should be studied in the future and test the dose on a greater number of participants. The researchers will test how the body absorbs and processes different doses of BA3011 by taking blood samples. In addition to receiving BA3011, you will also be administered a granulocyte colony-stimulating factor (G-CSF) product that is used to stimulate the growth of "healthy" white blood cells in the bone marrow, once cancer treatment is given. There are two forms of G-CSF that are approved for use in cancer patients globally: filgrastim and pegfilgrastim. The procedures in this study include blood testing, clinic visits to receive study drugs, scans to check on the status of your disease, and an optional tumor biopsy. Cancers may include: bladder cancer, breast cancer, lung cancer, cervical cancer, ovarian cancer, pancreatic cancer, stomach cancer, colon cancer, rectal cancer, head and neck cancer, oral cancer, liver cancer, melanoma, and prostate cancer.
This study is closed
Investigator
Prabhjot Mundi, MD
Are you 18 years of age or older? |
Yes |
No |
Do you have a life expectancy of at least 3 months? |
Yes |
No |
Are you able to provide a tissue sample? |
Yes |
No |
Have you been diagnosed with an advanced solid tumor (such as above) that has failed standard of care therapy? |
Yes |
No |