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.

Contact

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

Protocol
25-146
Phase
Phase I (phase 1)
Investigator
Co-Investigators
Diseases
ClinicalTrials.gov ID
NCT06778863