A Phase 1 Study of CLSP-1025 in People With Advanced Solid Tumors

Full Title

GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients with Solid Tumors That Harbor the P53 R175H Mutation

Purpose

Researchers are seeking the best dose of CLSP-1025 to use in people with advanced solid tumors. The people in this study have cancers with a mutation (change) in the p53 gene called R175H. They are also positive for a specific human leukocyte antigen (HLA type A*0201). HLA is a protein on cells that plays an important role in the immune response to foreign substances.

CLSP-1025 is a type of drug called a T cell engager (TCE). TCEs redirect T cells, a type of white blood cell in the immune system, to attack cancer cells.

TCEs are made up of 2 antibody pieces. One binds to a cancer cell and the other binds to a molecule on a T cell. This binding brings the T cell and cancer cell close together. The T cell is then activated and releases molecules to kill the cancer cell.

Who Can Join

To join this study, there are a few conditions. You must:

• Have an advanced solid tumor that cannot be successfully treated with standard therapies.
• Have a tumor with a p53 R175H mutation.
• Be positive for HLA type A*0201.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Adam Schoenfeld’s office at 646-608-2091.