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

NCT06253871 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IAM1363-01
• Study Type: interventional
• Target: 383
• Locations: 8 countries
• Sites: 48

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

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

Outcome Measures

Primary Outcomes (8)

• Incidence and severity of dose limiting toxicities (DLTs) (Part 1 only)

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

  21 days

• Incidence and severity of adverse events (AEs)

  Incidence of treatment emergent AEs (TEAEs) and serious adverse events (SAEs)

  Through 30 days after the last dose of study drug

• Pharmacokinetic (PK) parameters

  PK parameters. Includes but is not limited to assessment of maximum concentration (Cmax).

  Up to 42 days

• Confirmed objective response rate (cORR)

  Percentage of participants who achieve a confirmed objective response (complete response \[CR\] + partial response \[PR\]) per the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

  Through study completion, estimated as 46 months

• Confirmed central nervous system ORR (CNS-cORR)

  Percentage of participants who achieve a confirmed CNS-cORR (CNS-CR + CNS-PR) per the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) Criteria

  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

  As measured using standard ECG parameters, including pulse rate, QT intervals, and QRS duration.

  Through 30 days after the last dose of study drug

Secondary Outcomes (6)

• Best overall response (BoR) rate

  Through study completion, estimated as 46 months

• Duration of response (DoR)

  Through study completion, estimated as 46 months

• Disease control rate (DCR)

  Through study completion, estimated as 46 months

• Clinical benefit rate (CBR)

  Through study completion, estimated as 46 months

• Progression-free survival (PFS)

  Through study completion, estimated as 46 months

Study Arms (1)

IAM1363 Monotherapy or Combination Therapy

EXPERIMENTAL

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

Drug: IAM1363

Interventions

IAM1363 DRUG

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

IAM1363 Monotherapy or Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iambic Therapeutics, Inc: lead

Study Sites (48)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90089, United States

RECRUITING

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Comprehensive Hematology Oncology

St. Petersburg, Florida, 33709, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Henry Ford Cancer Institute

Detroit, Michigan, 48202, United States

RECRUITING

START - Midwest Cancer Research Center

Grand Rapids, Michigan, 49546, United States

RECRUITING

Saint Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

RUTGERS Cancer Institute

New Brunswick, New Jersey, 08901, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Duke Cancer Institute

Durham, North Carolina, 27710, United States

RECRUITING

University Hospital Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Providence Cancer Institute

Portland, Oregon, 97213, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

NEXT Oncology - Austin

Austin, Texas, 78758, United States

RECRUITING

NEXT Oncology - Dallas

Dallas, Texas, 75039, United States

RECRUITING

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

RECRUITING

MD Anderson Cancer Center - University of Texas

Houston, Texas, 77030, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

NEXT Oncology - Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Centre Georges François Leclerc

Dijon, 21079, France

RECRUITING

Institut de Cancerologie de l'Ouest

Saint-Herblain, 44805, France

RECRUITING

Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole Institut Claudius Regaud "

Toulouse, 31059, France

RECRUITING

The START center Dublin

Dublin, Dublin, D07 R2WY, Ireland

RECRUITING

Cork University Hospital, Wilton

Cork, T12DC4A, Ireland

RECRUITING

St. Vincent's University Hospital

Dublin, D04 T6F4, Ireland

RECRUITING

Azienda Ospedaliero Universitaria Careggi - Largo Giovanni Alessandro Brambilla 3

Florence, 50134, Italy

RECRUITING

Istituto Europeo di Oncologia (IEO)

Milan, 20141, Italy

RECRUITING

Netherlands Cancer Institute-Antoni van Leeuwenhoek

Amsterdam, 1066CX, Netherlands

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital - Yonsei Cancer Center

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Hospital Universitario Vall dHebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

START Madrid CIOCC, Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

RECRUITING

Hospital Clinico Universitario de Valencia (INCLIVA)

Valencia, 46010, Spain

RECRUITING

Oxford University Hospitals NHS Foundation Trust Churchill Hospital

Oxford, OX3 7LE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Stomach Neoplasms; Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Iambic Therapeutics, Inc., Senior Medical Director

  Iambic Therapeutics, Inc

  STUDY DIRECTOR

Central Study Contacts

Iambic Therapeutics, Inc., Senior Medical Director

CONTACT

619-330-5499; ClinicalTrials@Iambic.ai

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose-escalation and dose optimization

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: March 25, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

NL (1); KR (4); US (29); IE (3); GB (1); FR (3); IT (2); ES (5)