Actively Recruiting
A Phase 1/1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations
Led by Iambic Therapeutics, Inc · Updated on 2026-06-04
383
Participants Needed
53
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IAM1363, an investigational drug, in a Phase 1/1b open-label study involving participants with advanced cancers that have HER2 alterations. The study aims to assess the safety and early effects of IAM1363 in these patients, including those with brain metastases. This trial includes multiple parts focusing on dose escalation, dose optimization, expansion in specific tumor types, and combination with other anti-cancer treatments. The study has four parts: Part 1 involves escalating doses of IAM1363 as a monotherapy to find the maximum tolerated dose. Part 2 optimizes the dose based on safety and preliminary efficacy results. Part 3 expands to tumor-specific groups using the selected dose. Part 4 studies IAM1363 combined with other cancer drugs. Treatments are given orally in 14- or 21-day cycles. Participants will undergo evaluations including monitoring for dose-limiting toxicities, adverse events, and laboratory abnormalities. Researchers will measure responses in tumors and the central nervous system, pharmacokinetics, and treatment modifications. Follow-up will continue through study completion, estimated at about 46 months. Safety is closely monitored during and after treatment, with assessments of heart function and other clinical measures.
CONDITIONS
Brief Title
A Phase 1/1b Study of IAM1363 in HER2 Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Have relapsed or refractory HER2-altered cancer
- For selected groups, prospective confirmation of HER2 alteration by central testing is required
- Disease progression after last systemic therapy or intolerance to last therapy
- Measurable disease by RECIST v1.1 and/or RANO-BM
- ECOG performance status of 0 or 1
- Adequate hematologic, liver, and kidney function at baseline
- Left ventricular ejection fraction of 50% or higher
- Able to swallow oral medication
You will not qualify if you...
- Clinically significant heart disease
- Active infection with HIV-1 or HIV-2 (except well-controlled HIV with CD4 >350/mm3 and undetectable viral load)
- Active liver disease including hepatitis A, B, or C
- Conditions preventing adequate absorption such as refractory nausea, vomiting, malabsorption, external biliary shunt, or major small bowel resection
- 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 treatment
- Prior non-infectious interstitial lung disease (except resolved Grade 1 cases)
- Need for immediate local therapy for brain metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 46 months or until disease progression or discontinuation
Participants receive IAM1363 capsules orally, either alone or in combination with other anti-cancer agents, in 14- or 21-day cycles.
Repeated visits every 14 or 21 days per treatment cycle
Duration - Up to 30 days after the last dose of study drug
Participants are monitored for safety and response through study completion after treatment ends.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 53 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
Dartmouth Hitchcock Medical
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
15
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
16
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
17
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
18
University Hospital Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
19
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
20
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
21
Providence Cancer Institute
Portland, Oregon, United States, 97213
Actively Recruiting
22
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
23
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
24
NEXT Oncology - Austin
Austin, Texas, United States, 78758
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
Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
39
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, Italy, 80131
Actively Recruiting
40
Netherlands Cancer Institute-Antoni van Leeuwenhoek
Amsterdam, Netherlands, 1066CX
Actively Recruiting
41
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
42
Severance Hospital - Yonsei Cancer Center
Seoul, South Korea, 03722
Actively Recruiting
43
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
44
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
45
Hospital Universitario Vall dHebron
Barcelona, Spain, 08035
Actively Recruiting
46
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
47
START Madrid CIOCC, Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
48
Hospital Universitario Regional Málaga
Málaga, Spain, 29011
Actively Recruiting
49
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
50
Hospital Clinico Universitario de Valencia (INCLIVA)
Valencia, Spain, 46010
Actively Recruiting
51
Royal Marsden NHS Foundation Trust, Royal Marsden Hospital (RMH)/Chelsea)
Chelsea, United Kingdom, SW3 6JJ
Actively Recruiting
52
Oxford University Hospitals NHS Foundation Trust Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
53
Royal Marsden NHS Foundation Trust, Royal Marsden Hospital (RMH)/Sutton
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
I
Iambic Therapeutics, Inc., Senior Medical Director
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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