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

June 2, 2026 updated by: Iambic Therapeutics, Inc

A Phase 1/1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1/1b open-label, multi-center study, designed to evaluate IAM1363 in participants with advanced cancers that harbor HER2 alterations.

This study consists of the following 4 parts:

  • Part 1 (Monotherapy Dose Escalation)
  • Part 2 (Dose Optimization)
  • Part 3 (Dose Expansion)
  • Part 4 (Combination Cohorts)

Part 1 will enroll participants with a confirmed, relapsed/refractory malignancy with documented diagnosis of HER2 alterations including participants with brain metastases. Once a provisional maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) has been determined, Part 2 will enroll additional cohorts to optimize dose selection and to further evaluate the safety and preliminary efficacy of IAM1363. Following completion of Dose Optimization, Part 3 will be opened to enroll tumor-specific cohorts utilizing a Simon 2-Stage Minimax Design to evaluate IAM1363 at the selected dose(s).

Part 4 will enroll 4 cohorts of participants who will receive IAM1363 in combination with other anti-cancer agents.

Study Type

Interventional

Enrollment (Estimated)

383

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Dijon, France, 21079
        • Recruiting
        • Centre Georges Francois Leclerc
      • Saint-Herblain, France, 44805
        • Recruiting
        • Institut de cancerologie de l'ouest
      • Toulouse, France, 31059
        • Recruiting
        • Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole Institut Claudius Regaud "
  • Ireland
      • Cork, Ireland, T12DC4A
        • Recruiting
        • Cork University Hospital, Wilton
      • Dublin, Ireland, D04 T6F4
        • Recruiting
        • St. Vincent'S University Hospital
    • Dublin
      • Dublin, Dublin, Ireland, D07 R2WY
        • Recruiting
        • The START center Dublin
  • Italy
      • Florence, Italy, 50134
        • Recruiting
        • Azienda Ospedaliero Universitaria Careggi - Largo Giovanni Alessandro Brambilla 3
      • Milan, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia (IEO)
      • Milan, Italy, 20162
        • Recruiting
        • Grande Ospedale Metropolitano Niguarda
      • Naples, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Luigi Vanvitelli
  • Netherlands
      • Amsterdam, Netherlands, 1066CX
        • Recruiting
        • Netherlands Cancer Institute-Antoni van Leeuwenhoek
  • South Korea
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital - Yonsei Cancer Center
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall dHebron
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28050
        • Recruiting
        • START Madrid CIOCC, Hospital Universitario HM Sanchinarro
      • Málaga, Spain, 29011
        • Recruiting
        • Hospital Universitario Regional Málaga
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia (INCLIVA)
  • United Kingdom
      • Chelsea, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden NHS Foundation Trust, Royal Marsden Hospital (RMH)/Chelsea)
      • Oxford, United Kingdom, OX3 7LE
        • Recruiting
        • Oxford University Hospitals NHS Foundation Trust Churchill Hospital
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden NHS Foundation Trust, Royal Marsden Hospital (RMH)/Sutton
  • United States
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • UCSD Moores Cancer Center
      • Los Angeles, California, United States, 90089
        • Recruiting
        • USC Norris Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Cancer Center
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
      • St. Petersburg, Florida, United States, 33709
        • Recruiting
        • Comprehensive Hematology Oncology
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Cancer Institute
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • START - Midwest Cancer Research Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Cancer Institute
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Institute
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospital Cleveland Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health Stephenson Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Cancer Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt Ingram Cancer Center
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • NEXT Oncology - Austin
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Mary Crowley Cancer Research
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center - University of Texas
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • START Mountain Region
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Oncology - Virginia Cancer Specialists
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of dose limiting toxicities (DLTs) (Part 1 only)
Time Frame: 21 days
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)
Time Frame: Through 30 days after the last dose of study drug
Incidence of treatment emergent AEs (TEAEs) and serious adverse events (SAEs)
Through 30 days after the last dose of study drug
Pharmacokinetic (PK) parameters
Time Frame: Up to 42 days
PK parameters. Includes but is not limited to assessment of maximum concentration (Cmax).
Up to 42 days
Confirmed objective response rate (cORR)
Time Frame: Through study completion, estimated as 46 months
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)
Time Frame: Through study completion, estimated as 46 months
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
Time Frame: Through 30 days after the last dose of study drug
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
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Through study completion, estimated as 46 months
OS defined as the number of months from the date of first study treatment administration to the date of death, irrespective of cause
Through study completion, estimated as 46 months
Best overall response (BoR) rate
Time Frame: Through study completion, estimated as 46 months
BoR defined as the best response per RECIST v1.1 and RANO-BM across all assessments
Through study completion, estimated as 46 months
Duration of response (DoR)
Time Frame: Through study completion, estimated as 46 months
DoR defined as the time between the first confirmed objective response per RECIST v1.1 and RANO-BM and date of disease progression per RECIST v1.1 and RANO-BM or death due to any cause
Through study completion, estimated as 46 months
Disease control rate (DCR)
Time Frame: Through study completion, estimated as 46 months
DCR defined as the percentage of participants who achieve CR or PR, or stable disease (SD) per RECIST v1.1 and RANO-BM
Through study completion, estimated as 46 months
Clinical benefit rate (CBR)
Time Frame: Through study completion, estimated as 46 months
CBR defined as the percentage of participants who achieve CR, PR, or SD per RECIST v1.1 and RANO-BM consecutively for 3 months
Through study completion, estimated as 46 months
Progression-free survival (PFS)
Time Frame: Through study completion, estimated as 46 months
PFS defined as the number of months from the date of first study treatment administration to the earliest of documented progressive disease per RECIST v1.1 and RANO-BM or death without prior progression
Through study completion, estimated as 46 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iambic Therapeutics, Inc

Investigators

  • Study Director: Iambic Therapeutics, Inc., Senior Medical Director, Iambic Therapeutics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAM1363-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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