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

Part of paid clinical trials in La Jolla, California.

Sponsor
Iambic Therapeutics, Inc
Study ID
NCT06253871
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Mar 25, 2024
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
383 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Incidence and severity of dose limiting toxicities (DLTs) (Part 1 only) [ Time Frame: 21 days ]

Central Contacts

Locations (29)

FacilityCityStateZIPSite coordinators
UCSD Moores Cancer CenterLa JollaCalifornia92093-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90089-
University of Colorado Cancer CenterAuroraColorado80045-
University of MiamiMiamiFlorida33136-
Comprehensive Hematology OncologySt. PetersburgFlorida33709-
University of ChicagoChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
Henry Ford Cancer InstituteDetroitMichigan48202-
START - Midwest Cancer Research CenterGrand RapidsMichigan49546-
Saint Luke's Cancer InstituteKansas CityMissouri64111-
Washington University School of MedicineSt LouisMissouri63110-
Dartmouth Hitchcock MedicalLebanonNew Hampshire03756-
Rutgers Cancer InstituteNew BrunswickNew Jersey08901-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Duke Cancer InstituteDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
University Hospital Cleveland Medical CenterClevelandOhio44106-
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73104-
Providence Cancer InstitutePortlandOregon97213-
SCRI Oncology PartnersNashvilleTennessee37203-
Vanderbilt Ingram Cancer CenterNashvilleTennessee37232-
NEXT Oncology - AustinAustinTexas78758-
Mary Crowley Cancer ResearchDallasTexas75230-
MD Anderson Cancer Center - University of TexasHoustonTexas77030-
START Mountain RegionWest Valley CityUtah84119-
NEXT Oncology - Virginia Cancer SpecialistsFairfaxVirginia22031-
Fred Hutchinson Cancer CenterSeattleWashington98109-

Find similar trials in La Jolla, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UCSD Moores Cancer Center· La Jolla, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of Colorado Cancer Center· Aurora, COUniversity of Miami· Miami, FLComprehensive Hematology Oncology· St. Petersburg, FLUniversity of Chicago· Chicago, IL

Related Studies