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

a study on HER2 Breast Cancer Brain Cancer Solid Tumor CNS Metastases Lung Cancer Non-Small Cell Lung Cancer Bladder Cancer Colorectal Cancer Stomach Cancer Esophageal Cancer Neoplasms Brain Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

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.

Official Title

A Phase 1/1b Study of IAM1363 in Patients With Advanced Cancers Harboring HER2 Alterations

Details

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).

Keywords

HER2 Mutation-Related Tumors, HER2, HER2-positive Breast Cancer, HER2 + Breast Cancer, Brain Metastases From Solid Tumors, Brain Metastases From HER2 and Breast Cancer, CNS Metastases, HER2-Positive Solid Tumors, NSCLC (Non-small Cell Lung Cancer), HER2-positive Bladder Cancer, HER2-positive Colorectal Cancer, HER2 + Gastric Cancer, HER2-positive Gastroesophageal Cancer, ERBB2 protein, human, Molecular Targeted Therapy, Genes, erbB-2, Receptor, ErbB-2 / antagonists & inhibitors, Neoplasms / drug therapy, HER2 positive, HER2 overexpressing, HER2 altered, Human epidermal growth factor receptor, ErbB Receptors, brain metastases, Breast Neoplasms, Non-Small-Cell Lung Carcinoma, Stomach Neoplasms, Neoplasms, Brain Neoplasms, IAM1363, IAM1363 Monotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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%

You CAN'T join if...

  • 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

Locations

  • UCSD Moores Cancer Center accepting new patients
    La Jolla 5363943 California 5332921 92093-0819 United States
  • USC Norris Comprehensive Cancer Center accepting new patients
    Los Angeles 5368361 California 5332921 90089 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Iambic Therapeutics, Inc
ID
NCT06253871
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 243 study participants
Last Updated
Contact us about this trial