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NCT06253871 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of HER2-positive Breast Cancer and NSCLC (Non-small Cell Lung Cancer), sponsored by Iambic Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
243
Enrollment target
20
Study locations

NCT06253871: Recruiting Phase 1 study of HER2-positive Breast Cancer and NSCLC (Non-small Cell Lung Cancer), sponsored by Iambic Therapeutics.

NCT06253871 is a Phase 1 study of HER2-positive Breast Cancer and NSCLC (Non-small Cell Lung Cancer) that is actively recruiting participants, run by Iambic Therapeutics. The registered enrollment target is 243 participants, roughly in line with the 232-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06253871, a Phase 1 study of HER2-positive Breast Cancer and NSCLC (Non-small Cell Lung Cancer), is actively recruiting participants, sponsored by Iambic Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
243 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Incidence and severity of DLTs during the first cycle of treatment in participants in Part 1

Conditions Studied

HER2-positive Breast Cancer NSCLC (Non-small Cell Lung Cancer) HER2 + Breast Cancer HER2 Mutation-Related Tumors Brain Metastases From Solid Tumors HER2 HER2-Positive Solid Tumors HER2-positive Bladder Cancer Brain Metastases From HER2 and Breast Cancer CNS Metastases

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

FieldValue
Enrollment Target 243 participants
Start Date 2024-03-25
Est. Completion 2028-03
Phase Phase 1
Iambic Therapeutics

1 total trials

What NCT06253871 shows while recruiting

NCT06253871 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 232-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target.

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.

NCT06253871 names 20 study sites across 14 states, led by Michigan, California, Florida.

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.

What interventions are being tested in trial NCT06253871?

The interventions under investigation include: IAM1363 (DRUG).

Who is sponsoring clinical trial NCT06253871?

This trial is sponsored by Iambic Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for HER2-positive Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06253871's enrollment target sits among peer trials

243 11th of 58 higher than 48 of 58 other HER2-positive Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HER2-positive Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06253871

Source: ClinicalTrials.gov NCT06253871, the US trial registry maintained by the National Library of Medicine. NCT06253871 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.