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

Status: Recruiting
Location: See all (53) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
UCSD Moores Cancer Center
RECRUITING
La Jolla
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Colorado
University of Colorado Cancer Center
RECRUITING
Aurora
Florida
University of Miami
RECRUITING
Miami
Comprehensive Hematology Oncology
RECRUITING
St. Petersburg
Illinois
University of Chicago
RECRUITING
Chicago
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Michigan
University of Michigan
RECRUITING
Ann Arbor
Henry Ford Cancer Institute
RECRUITING
Detroit
START - Midwest Cancer Research Center
RECRUITING
Grand Rapids
Missouri
Saint Luke's Cancer Institute
RECRUITING
Kansas City
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Duke Cancer Institute
RECRUITING
Durham
New Hampshire
Dartmouth Hitchcock Medical
RECRUITING
Lebanon
New Jersey
Rutgers Cancer Institute
RECRUITING
New Brunswick
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
University Hospital Cleveland Medical Center
RECRUITING
Cleveland
Oklahoma
OU Health Stephenson Cancer Center
RECRUITING
Oklahoma City
Oregon
Providence Cancer Institute
RECRUITING
Portland
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Vanderbilt Ingram Cancer Center
RECRUITING
Nashville
Texas
NEXT Oncology - Austin
RECRUITING
Austin
Mary Crowley Cancer Research
RECRUITING
Dallas
MD Anderson Cancer Center - University of Texas
RECRUITING
Houston
Utah
START Mountain Region
RECRUITING
West Valley City
Virginia
NEXT Oncology - Virginia Cancer Specialists
RECRUITING
Fairfax
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Other Locations
France
Centre Georges François Leclerc
RECRUITING
Dijon
Institut de Cancerologie de l'Ouest
RECRUITING
Saint-herblain
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole Institut Claudius Regaud
RECRUITING
Toulouse
Ireland
Cork University Hospital, Wilton
RECRUITING
Cork
St. Vincent's University Hospital
RECRUITING
Dublin
The START center Dublin
RECRUITING
Dublin
Italy
Azienda Ospedaliero Universitaria Careggi - Largo Giovanni Alessandro Brambilla 3
RECRUITING
Florence
Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Istituto Europeo di Oncologia (IEO)
RECRUITING
Milan
Azienda Ospedaliera Universitaria Luigi Vanvitelli
RECRUITING
Naples
Netherlands
Netherlands Cancer Institute-Antoni van Leeuwenhoek
RECRUITING
Amsterdam
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital - Yonsei Cancer Center
RECRUITING
Seoul
Spain
Hospital Universitario Vall dHebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
START Madrid CIOCC, Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Hospital Universitario Regional Málaga
RECRUITING
Málaga
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Hospital Clinico Universitario de Valencia (INCLIVA)
RECRUITING
Valencia
United Kingdom
Royal Marsden NHS Foundation Trust, Royal Marsden Hospital (RMH)/Chelsea)
RECRUITING
Chelsea
Oxford University Hospitals NHS Foundation Trust Churchill Hospital
RECRUITING
Oxford
Royal Marsden NHS Foundation Trust, Royal Marsden Hospital (RMH)/Sutton
RECRUITING
Sutton
Contact Information
Primary
Iambic Therapeutics, Inc., Senior Medical Director
ClinicalTrials@Iambic.ai
619-330-5499
Time Frame
Start Date: 2024-03-25
Estimated Completion Date: 2028-12
Participants
Target number of participants: 383
Treatments
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.
Sponsors
Leads: Iambic Therapeutics, Inc

This content was sourced from clinicaltrials.gov

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