Clasp_CLSP-1025-101

What is the Purpose of this Study?

In this study, people will get a medicine called CLSP-1025 through a needle in their arm. They may need to stay in the hospital for 2 days after the first two doses. They will have regular checkups, tests, and scans. The study can last up to 2 years if the medicine helps and they feel okay. Everyone in the study gets the medicine - no one gets a fake treatment.

What is the Condition Being Studied?

This study is for people with solid tumors who have a special gene change called p53 R175H and a certain immune marker called HLA-A*02:01.

Who Can Participate in the Study?

You may be able to join this study if you are 18 or older, have a solid tumor with a special gene change called p53 R175H, and test positive for a marker called HLA-A*02:01. You cannot join if you have certain other markers, are pregnant or breastfeeding, and you must agree to use birth control.

Age Group
Adults

What is Involved?

This study is testing a new medicine called CLSP-1025 to see if it is safe and if it can help shrink or control tumors. The medicine is designed to help the body's immune system find and attack cancer cells with a special gene change.

Study Details

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
Principal Investigator
Instructor in the Department of Medicine
Protocol Number
IRB: PRO00118710
NCT: NCT06778863
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL