A Phase 1/1b Study of IAM1363 in HER2 Cancers
A Phase 1/1b Study of IAM1363 in HER2 Cancers
This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.
Miscellaneous
Phase I
Adults
Mol. targeted/Immunotherapy/Biologics
IAM1363
Kennedy, Laura
National
Vanderbilt University
11-05-2025
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
Age 18 years
Have relapsed/refractory HER2-altered malignancy
Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy
Have radiographically measurable disease by RECIST v1.1 and/or RANO-BM
Eastern Cooperative Oncology Group (ECOG) performance score 0-1
Have adequate baseline hematologic, liver and renal function
Have left ventricular ejection fraction (LVEF) 50%
Exclusion Criteria:
Clinically significant cardiac disease
Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Patients with well-controlled HIV (e.g., CD4 >350/mm3 and undetectable viral load) are eligible
Current active liver disease including hepatitis A, hepatitis B , or hepatitis C
Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption
Uncontrolled diabetes
History of solid organ transplantation
History of Grade 2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1
Patients requiring immediate local therapy for brain metastases
Age 18 years
Have relapsed/refractory HER2-altered malignancy
Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy
Have radiographically measurable disease by RECIST v1.1 and/or RANO-BM
Eastern Cooperative Oncology Group (ECOG) performance score 0-1
Have adequate baseline hematologic, liver and renal function
Have left ventricular ejection fraction (LVEF) 50%
Exclusion Criteria:
Clinically significant cardiac disease
Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Patients with well-controlled HIV (e.g., CD4 >350/mm3 and undetectable viral load) are eligible
Current active liver disease including hepatitis A, hepatitis B , or hepatitis C
Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption
Uncontrolled diabetes
History of solid organ transplantation
History of Grade 2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1
Patients requiring immediate local therapy for brain metastases
