RECRUITING

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

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Conditions

HER2 Mutation-Related TumorsHER2HER2-positive Breast CancerHER2 + Breast CancerBrain Metastases from Solid TumorsBrain Metastases from HER2 and Breast CancerCNS MetastasesHER2-Positive Solid TumorsNSCLC (non-small Cell Lung Cancer)HER2-positive Bladder CancerHER2-positive Colorectal CancerHER2 + Gastric CancerHER2-positive Gastroesophageal CancerERBB2 protein, humanMolecular Targeted TherapyGenes, erbB-2Receptor, ErbB-2 / antagonists & inhibitorsNeoplasms / drug therapyHER2 positiveHER2 overexpressingHER2 alteredHuman epidermal growth factor receptorErbB Receptorsbrain metastases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-25
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06253871

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Have relapsed/refractory HER2-altered malignancy
  3. * Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy
  4. * Have radiographically measurable disease by RECIST v1.1 and/or RANO-BM
  5. * Eastern Cooperative Oncology Group (ECOG) performance score 0-1
  6. * Have adequate baseline hematologic, liver and renal function
  7. * Have left ventricular ejection fraction (LVEF) ≥ 50%
  1. * Clinically significant cardiac disease
  2. * 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
  3. * Current active liver disease including hepatitis A, hepatitis B , or hepatitis C
  4. * Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption
  5. * Uncontrolled diabetes
  6. * History of solid organ transplantation
  7. * History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1
  8. * Patients requiring immediate local therapy for brain metastases

Contacts and Locations

Study Contact

Iambic Therapeutics, Inc., Senior Medical Director
CONTACT
619-330-5499
ClinicalTrials@Iambic.ai

Principal Investigator

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

Study Locations (Sites)

USC Norris Comprehensive Cancer Center
Los Angeles, California, 90089
United States
Comprehensive Hematology Oncology
Saint Petersburg, Florida, 33709
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
START - Midwest Cancer Research Center
Grand Rapids, Michigan, 49546
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
NEXT Oncology - Austin
Austin, Texas, 78758
United States
NEXT Oncology - Dallas
Dallas, Texas, 75039
United States
Mary Crowley Cancer Research
Dallas, Texas, 75230
United States
START Mountain Region
West Valley City, Utah, 84119
United States
NEXT Oncology - Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Iambic Therapeutics, Inc

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-25
Study Completion Date2028-03

Study Record Updates

Study Start Date2024-03-25
Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

  • 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
  • HER2
  • brain metastases

Additional Relevant MeSH Terms

  • 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