Find a Research Study

Find a Research Study

Find a Research Study

Find a Research Study

Find a Research Study

A Phase 1/1b Study of IAM1363 in Participants with Advanced Cancers Harboring HER2 Alterations

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.


Why this Research Matters

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, which are described in further detail below: Part 1 (Monotherapy Dose Escalation) Part 2 (Dose Optimization) Part 3 (Simon 2-Stage Evaluation) Part 1 will enroll participants with a confirmed, relapsed/refractory malignancy with documented diagnosis of HER2 alterations including participants with brain metastases. Once a provisional maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) has been determined, Part 2 will enroll additional cohorts to optimize dose selection and to further evaluate the safety and preliminary efficacy of IAM1363. Following completion of Dose Optimization, Part 3 will be opened to enroll tumor-specific cohorts utilizing a Simon 2-Stage Minimax Design to evaluate IAM1363 at the selected dose(s).


Who can Participate

Adult

Detailed eligibility criteria is available on ClinicalTrials.gov. These requirements will be discussed with your doctor and/or study representative. ClinicalTrials.gov to learn more about this study. https://clinicaltrials.gov/study/NCT06253871?intr=IAM1363&rank=1


Study ID

Protocol Number: 25-0333

More information available at ClinicalTrials.gov: NCT06253871


Meet the Team

Image of Principal Investigator

Peter Kabos, MD

Principal Investigator