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.
Who Can Participate?
Eligibility
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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Christopher
Hoimes
Protocol Number
PRO00118710
NCT ID
NCT06778863
Phase
I
Enrollment Status
Pending Open to Enrollment