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A Phase 1/1b Study of IAM1363 in HER2 Cancers
NCT06253871 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG IAM1363
Study Locations (20)
Michigan
- University of Michigan — Ann Arbor
- Henry Ford Cancer Institute — Detroit
- START - Midwest Cancer Research Center — Grand Rapids
California
- UCSD Moores Cancer Center — La Jolla
- USC Norris Comprehensive Cancer Center — Los Angeles
Florida
- University of Miami — Miami
- Comprehensive Hematology Oncology — St. Petersburg
Missouri
- Saint Luke's Cancer Institute — Kansas City
- Washington University School of Medicine — St Louis
Ohio
- University Hospital Cleveland Medical Center — Cleveland
- Cleveland Clinic — Cleveland
Colorado
- University of Colorado Cancer Center — Aurora
Illinois
- University of Chicago — Chicago
Massachusetts
- Dana Farber Cancer Institute — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2024-03-25 |
| Est. Completion | 2028-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06253871
The ClinicalTrials.gov registry entry for NCT06253871 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 243 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Iambic Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 1 intervention — of which IAM1363 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06253871 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Michigan, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06253871 about?
NCT06253871 is a clinical study titled "A Phase 1/1b Study of IAM1363 in HER2 Cancers". 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.
What is the current status of trial NCT06253871?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 243 participants. The study started on 2024-03-25. Estimated completion is 2028-03.
What conditions does trial NCT06253871 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer, NSCLC (Non-small Cell Lung Cancer), HER2 + Breast Cancer, HER2 Mutation-Related Tumors, Brain Metastases From Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06253871?
The interventions under investigation include: IAM1363 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06253871?
This trial is sponsored by Iambic Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06253871 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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