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
- Amsterdam, NetherlandsSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an advanced cancer that has a HER2 change, has come back or not responded to treatment, and can be measured on scans.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Advanced cancer with a HER2 change that came back or did not respond to treatment. The disease must be measurable on scans (RECIST v1.1 and/or RANO-BM).
- Earlier treatment
- The disease must have grown after the last systemic therapy, or the person could not tolerate that therapy.
- Biomarker or test result
- A HER2 change. For some groups, it must be confirmed by central testing before joining.
Main reasons for not taking part
- Clinically significant heart disease
- Active liver disease, including hepatitis A, B or C
- Uncontrolled diabetes
- History of solid organ transplantation
- Brain metastases that need immediate local therapy
Read by machine on 9 November 2026.
Where in Netherlands
- Netherlands Cancer Institute-Antoni van LeeuwenhoekAmsterdam, NetherlandsTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.