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

NCT06253871 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 383

Last updated 2026-04-13

No results posted yet for this 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

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

Interventions

DRUG

IAM1363

IAM1363 monotherapy OR IAM1363 in combination with capecitabine + trastuzumab OR IAM1363 in combination with capecitabine + zanidatamab OR IAM1363 in combination with T-Dxd OR IAM1363 in combination with pembrolizumab +/- carboplatin and pemetrexed

Sponsors & Collaborators

  • Iambic Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Iambic Therapeutics, Inc., Senior Medical Director · Iambic Therapeutics, Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Ireland
  • Italy
  • Netherlands
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06253871 on ClinicalTrials.gov