Clinical trial · Interventional
A Phase 1/1b Study of IAM1363 in HER2 Cancers
A Phase 1/1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations
NCT06253871CI-TRIAL-00113626recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases From HER2 and Breast Cancer | — | UNRESOLVED | — |
| Brain Metastases From Solid Tumors | — | UNRESOLVED | — |
| CNS Metastases | — | UNRESOLVED | — |
| HER2 | — | UNRESOLVED | — |
| HER2 + Breast Cancer | — | UNRESOLVED | — |
| HER2 + Gastric Cancer | — | UNRESOLVED | — |
| HER2 Mutation-Related Tumors | — | UNRESOLVED | — |
| HER2-positive Bladder Cancer | — | UNRESOLVED | — |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| HER2-positive Colorectal Cancer | HER2-Positive Colorectal Carcinoma | ALIAS |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IAM1363 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IAM1363 Monotherapy or Combination Therapy
- description
- Treatment with IAM1363 capsules, dosed orally alone or in combination with other anti-cancer agents, in 14- or 21-day cycles.
- interventionNames
- Drug: IAM1363
Primary outcomes (8)
- measure
- Incidence and severity of dose limiting toxicities (DLTs) (Part 1 only)
- timeFrame
- 21 days
- description
- Incidence and severity of DLTs during the first cycle of treatment in participants in Part 1
- measure
- Incidence and severity of adverse events (AEs)
- timeFrame
- Through 30 days after the last dose of study drug
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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 * Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption * Uncontrolled diabetes * History of solid organ transplantation * 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
References
Publications (0)
Data not yet available
No reference posted for this study.