Status:
RECRUITING
A Phase 1/1b Study of IAM1363 in HER2 Cancers
Lead Sponsor:
Iambic Therapeutics, Inc
Conditions:
HER2 Mutation-Related Tumors
HER2
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
This is a Phase 1/1b open-label, multi-center study, designed to evaluate IAM1363 in participants with advanced cancers that harbor HER2 alterations. This study consists of the following 3 parts, whi...
Eligibility Criteria
Inclusion
- Key
- 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%
- Key
Exclusion
- 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
Key Trial Info
Start Date :
March 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT06253871
Start Date
March 25 2024
End Date
March 1 2028
Last Update
February 3 2026
Active Locations (45)
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1
UCSD Moores Cancer Center
La Jolla, California, United States, 92093-0819
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089
3
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
4
University of Miami
Miami, Florida, United States, 33139