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

Overview

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.

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 4 parts:

* Part 1 (Monotherapy Dose Escalation)
* Part 2 (Dose Optimization)
* Part 3 (Dose Expansion)
* Part 4 (Combination Cohorts)

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).

Part 4 will enroll 4 cohorts of participants who will receive IAM1363 in combination with other anti-cancer agents.

Who Can Participate

Inclusion Criteria

Age ≥ 18 years

Have relapsed/refractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required

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%

Able to swallow oral medication

Exclusion Criteria

Clinically significant cardiac disease

Infection 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 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

Prior 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

Disclaimer

This summary is based on publicly available information from clinicaltrials.gov and is intended to help patients discuss possible trial options with their oncology care team. ClinicalTrials.gov and related public listings do not independently review or approve the safety and scientific merit of every study.

Participation decisions can be made only after review by the study team and your treating clinician.