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Taking people in ItalyPhase 1

Tests IAM1363 in adults with advanced cancers that have HER2 changes

Tests IAM1363 for safety and dosing in adults with advanced HER2-altered cancers.

Key facts

Who runs it
Iambic Therapeutics, Inc
Where
Florence, Milan, and Naples, ItalySee the 4 sitesAlso in 7 other countries, 49 sites
Trial code
Registry title
A Phase 1/1b Study of IAM1363 in HER2 Cancers
Status
Recruiting
Phase
Phase 1
People taking part
383 people, planned
Started
25 Mar 2024
Expected to end
Dec 2028
Type of study
Interventional
Treatments tested
  • IAM1363
Record updated
9 September 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Italy

Also in 7 other countries, 49 sites

  • Azienda Ospedaliero Universitaria Careggi - Largo Giovanni Alessandro Brambilla 3Florence, ItalyContact: Iambic Therapeutics, Inc., Senior Medical DirectorTaking people
  • Grande Ospedale Metropolitano NiguardaMilan, ItalyContact: Iambic Therapeutics, Inc., Senior Medical DirectorTaking people
  • Istituto Europeo di Oncologia (IEO)Milan, ItalyContact: Iambic Therapeutics, Inc., Senior Medical DirectorTaking people
  • Azienda Ospedaliera Universitaria Luigi VanvitelliNaples, ItalyContact: Iambic Therapeutics, Inc., Senior Medical DirectorTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • IAM1363 Monotherapy or Combination TherapyTreatment being tested

    Treatment with IAM1363 capsules, dosed orally alone or in combination with other anti-cancer agents, in 14- or 21-day cycles.

    Treatment: IAM1363

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 1/1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations
Plain-language title
Tests IAM1363 in adults with advanced cancers that have HER2 changesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
9 September 2026