Tests IAM1363 in adults with advanced cancers that have HER2 changes
Tests IAM1363 for safety and dosing in adults with advanced HER2-altered cancers.
Plain-language title generated from the registry record
Registry title: A Phase 1/1b Study of IAM1363 in HER2 Cancers
Key facts
- Where
- Florence, Milan, and Naples, ItalySee the 4 sites
- Phase
- Phase 1
Where in Italy
- Azienda Ospedaliero Universitaria Careggi - Largo Giovanni Alessandro Brambilla 3Florence, ItalyTaking people
- Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Istituto Europeo di Oncologia (IEO)Milan, ItalyTaking people
- Azienda Ospedaliera Universitaria Luigi VanvitelliNaples, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Iambic Therapeutics, Inc
- Trial code
- NCT06253871
- Record updated
- 9 September 2026
- Original description
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.Read full original descriptionShow less
A Phase 1/1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations
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.
Inclusion: 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.
Exclusion: Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption; 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; 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; Uncontrolled diabetes; History of solid organ transplantation.