Clasp_CLSP-1025-101 - Clinical Trial

¿Cuál es el Propósito de este estudio?

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.

¿Cuál es la Condición que se está estudiando?

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.

¿Quién puede participar en el Estudio?

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.

Grupo etario
Adultos

¿Qué Implica?

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.

Detalles del Estudio

Título Completo
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
Investigador Principal
Número de Protocolo
IRB: PRO00118710
NCT: NCT06778863
Fase
Fase I
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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