A Phase I/Ib Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations
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Study Summary
This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study, designed to evaluate safety and preliminary efficacy of IAM1363 as monotherapy and in combination with trastuzumab in patients with advanced cancers that harbor HER2 alterations.
To evaluate IAM1363 as monotherapy and in combination with trastuzumab
To establish the safety and tolerability of IAM1363, characterize PK/PD, and determine the recommended Phase 2 dose.
To establish the safety profile of IAM1363 as a single agent and in combination with trastuzumab and to provide initial proof of antitumor activity in malignancies with HER2 overexpression, gene amplification, or tyrosine kinase mutations, including in patients with brain metastases.
To evaluate IAM1363 in combination with zanidatamab and capecitabine.
To identify the maximum tolerated/maximum administered dose (MTD/MAD) and evaluate safety and preliminary activity.
- Age ≥ 18 yearsHave relapsed/refractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is requiredHave progression of disease after the last systemic therapy, or be intolerant of last systemic therapyHave radiographically measurable disease by RECIST v1.1 and/or RANO-BMEastern Cooperative Oncology Group (ECOG) performance score 0-1Have adequate baseline hematologic, liver and renal functionHave left ventricular ejection fraction (LVEF) ≥ 50%Able to swallow oral medication
- Clinically significant cardiac diseaseInfection 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 eligibleCurrent active liver disease including hepatitis A, hepatitis B , or hepatitis CRefractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorptionUncontrolled diabetesHistory of solid organ transplantationHistory of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1Prior 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
Clinical Study Information for Healthcare Providers
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