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OncoMatch/Clinical Trials/NCT06253871

A Phase 1/1b Study of IAM1363 in HER2 Cancers

Is NCT06253871 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies IAM1363 for her2 mutation-related tumors.

Phase 1RecruitingIambic Therapeutics, IncNCT06253871Data as of Jun 2026Location: International · 7 countries

Treatment: IAM1363This 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.

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Extracted eligibility criteria

Treatments studied

Other

IAM1363

Cancer type

Breast Carcinoma

Tumor Agnostic

Non-Small Cell Lung Carcinoma

Urothelial Carcinoma

Colorectal Cancer

Gastric Cancer

Esophageal Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) altered

Have relapsed/refractory HER2-altered malignancy

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: systemic therapy

Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy

Lab requirements

Blood counts

adequate baseline hematologic function

Kidney function

adequate baseline renal function

Liver function

adequate baseline liver function

Cardiac function

left ventricular ejection fraction (lvef) ≥ 50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UCSD Moores Cancer Center · La Jolla, California
  • USC Norris Comprehensive Cancer Center · Los Angeles, California
  • University of Colorado Cancer Center · Aurora, Colorado
  • University of Miami · Miami, Florida
  • Comprehensive Hematology Oncology · St. Petersburg, Florida

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06253871 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received systemic therapy.

Does this trial require ERBB2?

Yes, ERBB2 altered is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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