ClinicaliQ Trial Snapshot
- A Phase 1/1b Study of IAM1363 in HER2 Cancers — Recruiting • Phase I • Oncology • NCT06253871.
- What is being tested: IAM1363, a novel therapeutic agent, is undergoing Phase 1/1b evaluation to assess its safety profile and preliminary efficacy in patients with advanced cancers harboring HER2 alterations through dose escalation and optimization.
- Patient eligibility overview: The trial enrolls participants with advanced cancers that contain HER2 genetic alterations; specific inclusion/exclusion criteria would determine prior treatment history, organ function, and performance status requirements.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.