Actively Recruiting
A Phase 1/1b Study of IAM1363 in HER2 Cancers
Led by Iambic Therapeutics, Inc · Updated on 2026-04-13
383
Participants Needed
48
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
A Phase 1/1b Study of IAM1363 in HER2 Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years
- Have relapsed or refractory HER2-altered cancer
- For selected groups, confirmation of HER2 alteration through central testing is required
- Disease progression after last systemic therapy or intolerance to last therapy
- Measurable disease by imaging using RECIST v1.1 and/or RANO-BM criteria
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
- Adequate blood, liver, and kidney function at baseline
- Left ventricular ejection fraction (LVEF) 65 50%
- Able to swallow oral medication
You will not qualify if you...
- Clinically significant heart disease
- Infection with HIV-1 or HIV-2 unless well controlled (CD4 >350/mm3 and undetectable viral load)
- Active liver disease including hepatitis A, B, or C
- Severe nausea, vomiting, malabsorption, external biliary shunt, or major small bowel surgery preventing proper absorption
- Uncontrolled diabetes
- History of solid organ transplant
- History of grade 2 or higher central nervous system hemorrhage or any CNS hemorrhage within 28 days before starting treatment
- Prior non-infectious interstitial lung disease except completely resolved grade 1 cases
- Need for immediate local treatment for brain metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 48 locations
1
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089
Actively Recruiting
3
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
4
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
5
Comprehensive Hematology Oncology
St. Petersburg, Florida, United States, 33709
Actively Recruiting
6
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
10
Henry Ford Cancer Institute
Detroit, Michigan, United States, 48202
Actively Recruiting
11
START - Midwest Cancer Research Center
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
12
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Actively Recruiting
13
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
14
RUTGERS Cancer Institute
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
15
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
16
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
17
University Hospital Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
18
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
19
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
20
Providence Cancer Institute
Portland, Oregon, United States, 97213
Actively Recruiting
21
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
22
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
23
NEXT Oncology - Austin
Austin, Texas, United States, 78758
Actively Recruiting
24
NEXT Oncology - Dallas
Dallas, Texas, United States, 75039
Actively Recruiting
25
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Actively Recruiting
26
MD Anderson Cancer Center - University of Texas
Houston, Texas, United States, 77030
Actively Recruiting
27
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
28
NEXT Oncology - Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
29
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
30
Centre Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
31
Institut de Cancerologie de l'Ouest
Saint-Herblain, France, 44805
Actively Recruiting
32
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole Institut Claudius Regaud "
Toulouse, France, 31059
Actively Recruiting
33
The START center Dublin
Dublin, Dublin, Ireland, D07 R2WY
Actively Recruiting
34
Cork University Hospital, Wilton
Cork, Ireland, T12DC4A
Actively Recruiting
35
St. Vincent's University Hospital
Dublin, Ireland, D04 T6F4
Actively Recruiting
36
Azienda Ospedaliero Universitaria Careggi - Largo Giovanni Alessandro Brambilla 3
Florence, Italy, 50134
Actively Recruiting
37
Istituto Europeo di Oncologia (IEO)
Milan, Italy, 20141
Actively Recruiting
38
Netherlands Cancer Institute-Antoni van Leeuwenhoek
Amsterdam, Netherlands, 1066CX
Actively Recruiting
39
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
40
Severance Hospital - Yonsei Cancer Center
Seoul, South Korea, 03722
Actively Recruiting
41
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
42
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
43
Hospital Universitario Vall dHebron
Barcelona, Spain, 08035
Actively Recruiting
44
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
45
START Madrid CIOCC, Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
46
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
47
Hospital Clinico Universitario de Valencia (INCLIVA)
Valencia, Spain, 46010
Actively Recruiting
48
Oxford University Hospitals NHS Foundation Trust Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
Research Team
I
Iambic Therapeutics, Inc., Senior Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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