Recruiting

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.

ClinicalTrials.gov IDNCT06253871

PhasePHASE1

Enrollment383

SponsorIambic Therapeutics, Inc

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

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

Primary outcomes

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

Eligibility information

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 locations

UCSD Moores Cancer Center, La Jolla, California 92093 United States
USC Norris Comprehensive Cancer Center, Los Angeles, California 90089 United States
University of Colorado Cancer Center, Aurora, Colorado 80045 United States
University of Miami, Miami, Florida 33136 United States
Comprehensive Hematology Oncology, St. Petersburg, Florida 33709 United States
University of Chicago, Chicago, Illinois 60637 United States
Massachusetts General Hospital, Boston, Massachusetts 02114 United States
Dana Farber Cancer Institute, Boston, Massachusetts 02215 United States
University of Michigan, Ann Arbor, Michigan 48109 United States
Henry Ford Cancer Institute, Detroit, Michigan 48202 United States

Showing 10 of 53 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.