A Phase 1/1b Study of IAM1363 in HER2 Cancers
Recruiting · NCT06253871 · Interventional (participants receive a specific treatment) · Lead sponsor: Iambic Therapeutics, Inc
View the official record on ClinicalTrials.gov →Interventions studied
IAM1363
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
- Key
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
Where it is running
53 locations listed across 19 US states.
- UCSD Moores Cancer Center - La Jolla, California, United States
- USC Norris Comprehensive Cancer Center - Los Angeles, California, United States
- University of Colorado Cancer Center - Aurora, Colorado, United States
- University of Miami - Miami, Florida, United States
- Comprehensive Hematology Oncology - St. Petersburg, Florida, United States
- University of Chicago - Chicago, Illinois, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- University of Michigan - Ann Arbor, Michigan, United States
- Henry Ford Cancer Institute - Detroit, Michigan, United States
- START - Midwest Cancer Research Center - Grand Rapids, Michigan, United States
- Saint Luke's Cancer Institute - Kansas City, Missouri, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Dartmouth Hitchcock Medical - Lebanon, New Hampshire, United States
- Rutgers Cancer Institute - New Brunswick, New Jersey, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Duke Cancer Institute - Durham, North Carolina, United States
- University Hospital Cleveland Medical Center - Cleveland, Ohio, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- OU Health Stephenson Cancer Center - Oklahoma City, Oklahoma, United States
- Providence Cancer Institute - Portland, Oregon, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- Vanderbilt Ingram Cancer Center - Nashville, Tennessee, United States
- NEXT Oncology - Austin - Austin, Texas, United States
- Mary Crowley Cancer Research - Dallas, Texas, United States
- MD Anderson Cancer Center - University of Texas - Houston, Texas, United States
- START Mountain Region - West Valley City, Utah, United States
- NEXT Oncology - Virginia Cancer Specialists - Fairfax, Virginia, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Netherlands Cancer Institute-Antoni van Leeuwenhoek - Amsterdam, Netherlands
- Hospital Universitario Vall dHebron - Barcelona, Spain
- Royal Marsden NHS Foundation Trust, Royal Marsden Hospital (RMH)/Chelsea) - Chelsea, United Kingdom
- Cork University Hospital, Wilton - Cork, Ireland
- Centre Georges François Leclerc - Dijon, France
- St. Vincent's University Hospital - Dublin, Ireland
- Azienda Ospedaliero Universitaria Careggi - Largo Giovanni Alessandro Brambilla 3 - Florence, Italy
- Hospital Universitario 12 de Octubre - Madrid, Spain
- START Madrid CIOCC, Hospital Universitario HM Sanchinarro - Madrid, Spain
- Istituto Europeo di Oncologia (IEO) - Milan, Italy
- Grande Ospedale Metropolitano Niguarda - Milan, Italy
- Hospital Universitario Regional Málaga - Málaga, Spain
- Azienda Ospedaliera Universitaria Luigi Vanvitelli - Naples, Italy
- Oxford University Hospitals NHS Foundation Trust Churchill Hospital - Oxford, United Kingdom
- Institut de Cancerologie de l'Ouest - Saint-Herblain, France
- Seoul National University Hospital - Seoul, South Korea
- Severance Hospital - Yonsei Cancer Center - Seoul, South Korea
- Asan Medical Center - Seoul, South Korea
- Samsung Medical Center - Seoul, South Korea
- Hospital Universitario Virgen del Rocio - Seville, Spain
- Royal Marsden NHS Foundation Trust, Royal Marsden Hospital (RMH)/Sutton - Sutton, United Kingdom
- Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole Institut Claudius Regaud " - Toulouse, France
- Hospital Clinico Universitario de Valencia (INCLIVA) - Valencia, Spain
- The START center Dublin - Dublin, Dublin, Ireland