Recruiting
Phase 1

IAM1363

Sponsor:

Iambic Therapeutics, Inc

Code:

NCT06253871

Conditions

HER2 Mutation-Related Tumors

HER2

HER2-positive Breast Cancer

HER2 + Breast Cancer

Brain Metastases From Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IAM1363

Study Details

Brief 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

Study ID

NCT06253871

Start date

Mar 25, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Exclusion Criteria:

  • Clinically significant cardiac disease
  • Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants with well-controlled HIV (e.g., CD4 >350/mm3 and undetectable viral load) are eligible
  • Current active liver disease including hepatitis A, hepatitis B , or hepatitis C
  • Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption
  • Uncontrolled diabetes
  • History of solid organ transplantation
  • History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1
  • Prior history of non-infectious interstitial lung disease (ILD). (Exceptions: participants with prior grade 1 ILD that has completely resolved are eligible)
  • Participants requiring immediate local therapy for brain metastases

Study Design

Enrollment

383 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IAM1363 Monotherapy or Combination Therapy

Treatment with IAM1363 capsules, dosed orally alone or in combination with other anti-cancer agents, in 14- or 21-day cycles.

Interventions

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

Primary outcome measure

  • Incidence and severity of dose limiting toxicities (DLTs) (Part 1 only) [ Time Frame: 21 days ]
  • Incidence and severity of adverse events (AEs) [ Time Frame: Through 30 days after the last dose of study drug ]
  • Pharmacokinetic (PK) parameters [ Time Frame: Up to 42 days ]
  • Confirmed objective response rate (cORR) [ Time Frame: Through study completion, estimated as 46 months ]
  • Confirmed central nervous system ORR (CNS-cORR) [ Time Frame: Through study completion, estimated as 46 months ]
  • Frequency of IAM1363 dose modifications, including treatment discontinuations [ Time Frame: Through 30 days after the last dose of study drug ]
  • Incidence and severity of clinical laboratory abnormalities [ Time Frame: Through 30 days post last dose of study drug ]
  • Incidence of ECG abnormalities [ Time Frame: Through 30 days after the last dose of study drug ]

Central Contacts and Locations

Central contacts

Iambic Therapeutics, Inc., Senior Medical Director

619-330-5499ClinicalTrials@Iambic.ai

Locations

UCSD Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90089

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

University of Miami

Recruiting

Miami, Florida, United States, 33136

Comprehensive Hematology Oncology

Recruiting

St. Petersburg, Florida, United States, 33709

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Henry Ford Cancer Institute

Recruiting

Detroit, Michigan, United States, 48202

START - Midwest Cancer Research Center

Recruiting

Grand Rapids, Michigan, United States, 49546

Saint Luke's Cancer Institute

Recruiting

Kansas City, Missouri, United States, 64111

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Dartmouth Hitchcock Medical

Recruiting

Lebanon, New Hampshire, United States, 03756

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08901

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

University Hospital Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

OU Health Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Providence Cancer Institute

Recruiting

Portland, Oregon, United States, 97213

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Vanderbilt Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

NEXT Oncology - Austin

Recruiting

Austin, Texas, United States, 78758

Mary Crowley Cancer Research

Recruiting

Dallas, Texas, United States, 75230

MD Anderson Cancer Center - University of Texas

Recruiting

Houston, Texas, United States, 77030

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

NEXT Oncology - Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

More Information

Sponsor

Iambic Therapeutics, Inc

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • ERBB2 protein, human
  • Molecular Targeted Therapy
  • Genes, erbB-2
  • Receptor, ErbB-2 / antagonists & inhibitors
  • Neoplasms / drug therapy
  • HER2 positive
  • HER2 overexpressing
  • HER2 altered
  • Human epidermal growth factor receptor
  • ErbB Receptors
  • HER2
  • brain metastases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Iambic Therapeutics, Inc on 2026-06-04.