A Phase 1/1b Study of IAM1363 in HER2 Cancers

ID#: NCT06253871

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: March 25, 2024

End Date: March 01, 2028

Contact Information:
Iambic Therapeutics, Inc., Senior Medical Director
619-330-5499
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: Key

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% Key

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
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