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
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
Capecitabine,
IAM1363,
Trastuzumab,
Zanidatamab
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; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required
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%
Able to swallow oral medication
Exclusion Criteria:
Clinically significant cardiac disease
Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants 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
Prior history of non-infectious interstitial lung disease (ILD). (Exceptions: participants with prior grade 1 ILD that has completely resolved are eligible)
Participants requiring immediate local therapy for brain metastases
Age 18 years
Have relapsed/refractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required
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%
Able to swallow oral medication
Exclusion Criteria:
Clinically significant cardiac disease
Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants 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
Prior history of non-infectious interstitial lung disease (ILD). (Exceptions: participants with prior grade 1 ILD that has completely resolved are eligible)
Participants requiring immediate local therapy for brain metastases
