Iambic IAM1363-01 (Cancers with HER2 Alterations) - Clinical Trial
¿Cuál es el Propósito de este estudio?
We are doing this study to find the most effective, safe dose of an experimental drug called IAM1363 (the study drug) for people who have advanced cancers harboring HER2 alterations.
¿Cuál es la Condición que se está estudiando?
Advanced Cancers Harboring HER2 Alterations
¿Quién puede participar en el Estudio?
Adults ages 18+ who:
- Have a relapsed/refractory form of cancer that does not respond to standard therapy, or no standard therapy exists that is likely to provide clinical benefit
- Have a left ventricular ejection fraction (LVEF) of at least 50%
For more information, contact the study team at ryan.woelfel@duke.edu.
Grupo etario
Adultos
¿Qué Implica?
This study is being conducted in 3 parts:
- Part 1 is called Dose Escalation, and about 126 participants will be enrolled in this part of the study. This part of the study will help us find out what doses of the study drug have the potential to be safe and beneficial.
- Part 2 is called Dose Optimization, and this part of the study will enroll about 40 participants. This part of the study will help us find out what dose of the study drug seems to be ideal.
- Part 3 will test the dose of selected in Part 2 in patients with specific types of cancer to see if it is effective. About 77 participants will be enrolled.
Participants in all parts of the study will take the study drug every day.
Detalles del Estudio
Título Completo
A Phase 1/1b Study of IAM1363 in Participants with Advanced Cancers Harboring HER2 Alterations
Investigador Principal
Laura Alder, MD
Especialista en oncología médica
Número de Protocolo
IRB:
PRO00117953
NCT:
NCT06253871
Fase
Fase I
ClinicalTrials.gov
Ver en ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción