A Phase 1/1b Study of IAM1363 in Patients with Advanced Cancers Harboring HER2 Alterations
Status: Recruiting
Location: See all (12) 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
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Florida
Comprehensive Hematology Oncology
RECRUITING
St. Petersburg
Michigan
University of Michigan
RECRUITING
Ann Arbor
START - Midwest Cancer Research Center
RECRUITING
Grand Rapids
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Oklahoma
OU Health Stephenson Cancer Center
RECRUITING
Oklahoma City
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
NEXT Oncology - Austin
RECRUITING
Austin
Mary Crowley Cancer Research
RECRUITING
Dallas
NEXT Oncology - Dallas
RECRUITING
Dallas
Utah
START Mountain Region
RECRUITING
West Valley City
Virginia
NEXT Oncology - Virginia Cancer Specialists
RECRUITING
Fairfax
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