A Phase 1/1b Study of IAM1363 in Patients With Advanced Cancers Harboring HER2 Alterations
Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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%
Locations
United States
California
UCSD Moores Cancer Center
RECRUITING
La Jolla
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Florida
University of Miami
RECRUITING
Miami
Comprehensive Hematology Oncology
RECRUITING
St. Petersburg
Illinois
University of Chicago
RECRUITING
Chicago
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Michigan
University of Michigan
RECRUITING
Ann Arbor
Henry Ford Cancer Institute
RECRUITING
Detroit
START - Midwest Cancer Research Center
RECRUITING
Grand Rapids
Missouri
Saint Luke's Cancer Institute
RECRUITING
Kansas City
Washington University School of Medicine
RECRUITING
St Louis
New Jersey
RUTGERS Cancer Institute
RECRUITING
New Brunswick
Ohio
Cleveland Clinic
RECRUITING
Cleveland
University Hospital Cleveland Medical Center
RECRUITING
Cleveland
Oklahoma
OU Health Stephenson Cancer Center
RECRUITING
Oklahoma City
Oregon
Providence Cancer Institute
RECRUITING
Portland
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
University of Colorado Cancer Center
RECRUITING
Nashville
Vanderbilt Ingram Cancer Center
RECRUITING
Nashville
Texas
NEXT Oncology - Austin
RECRUITING
Austin
Mary Crowley Cancer Research
RECRUITING
Dallas
NEXT Oncology - Dallas
RECRUITING
Dallas
MD Anderson Cancer Center - University of Texas
RECRUITING
Houston
Utah
START Mountain Region
RECRUITING
West Valley City
Virginia
NEXT Oncology - Virginia Cancer Specialists
RECRUITING
Fairfax
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Other Locations
Ireland
The START center Dublin
RECRUITING
Dublin
Spain
START Madrid CIOCC, Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Contact Information
Primary
Iambic Therapeutics, Inc., Senior Medical Director
ClinicalTrials@Iambic.ai
619-330-5499
Time Frame
Start Date: 2024-03-25
Estimated Completion Date: 2028-03
Participants
Target number of participants: 243
Treatments
Experimental: IAM1363 Monotherapy
Treatment with IAM1363 capsules, dosed orally either once or twice daily in 21-day cycles.
Related Therapeutic Areas
Sponsors
Leads: Iambic Therapeutics, Inc