RecruitingPhase 1NCT06253871
A Phase 1/1b Study of IAM1363 in HER2 Cancers
A Phase 1/1b Study of IAM1363 in Patients With Advanced Cancers Harboring HER2 Alterations
Sponsor
Iambic Therapeutics, Inc
Enrollment
243 participants
Start Date
Mar 25, 2024
Study Type
INTERVENTIONAL
Conditions
HER2-positive Breast CancerHER2 + Breast CancerHER2 Mutation-Related TumorsHER2Brain Metastases From Solid TumorsBrain Metastases From HER2 and Breast CancerCNS MetastasesHER2-Positive Solid TumorsNSCLC (Non-small Cell Lung Cancer)HER2-positive Bladder CancerHER2-positive Colorectal CancerHER2 + Gastric CancerHER2-positive Gastroesophageal Cancer
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 harbor HER2 alterations.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria8
- 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
Interventions
DRUGIAM1363
Oral, immediate release capsules of IAM1363
Locations(45)
View Full Details on ClinicalTrials.gov
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NCT06253871
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