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

Description

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.

Conditions

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

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Study Overview

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Study Details

Study 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.

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

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

Condition
HER2 Mutation-Related Tumors
Intervention / Treatment

-

Contacts and Locations

Los Angeles

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90089

Saint Petersburg

Comprehensive Hematology Oncology, Saint Petersburg, Florida, United States, 33709

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Grand Rapids

START - Midwest Cancer Research Center, Grand Rapids, Michigan, United States, 49546

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Oklahoma City

OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, United States, 73104

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

Austin

NEXT Oncology - Austin, Austin, Texas, United States, 78758

Dallas

NEXT Oncology - Dallas, Dallas, Texas, United States, 75039

Dallas

Mary Crowley Cancer Research, Dallas, Texas, United States, 75230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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%
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Iambic Therapeutics, Inc,

Iambic Therapeutics, Inc., Senior Medical Director, STUDY_DIRECTOR, Iambic Therapeutics, Inc

Study Record Dates

2028-03