Clinical trial • Phase I/II • Oncology
IAM1363 for HER2-altered relapsed/refractory malignancy | HER2 gene amplification
Phase I/II trial of IAM1363 for HER2-altered relapsed/refractory malignancy | HER2 gene amplification. None/Not specified-controlled. 136 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- HER2-altered relapsed/refractory malignancy | HER2 gene amplification
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 11-06-2025
- First CTIS Authorization Date
- 11-09-2025
Trial design
None/Not specified-controlled Phase I/II trial across 20 sites in France, Ireland, Italy and others.
- Comparator
- None/Not specified
- Biomarker Stratified
- True, biomarker: HER2 alterations
- Target Sample Size
- 136
Recruitment
- Planned Sample Size
- 136
- Recruitment Window Months
- 21
Geography
- Total Number Of Sites
- 20
- Total Number Of Participants
- 97
France
- Earliest CTIS Part Ii Submission Date
- 24-07-2025
- Latest Decision Or Authorization Date
- 11-09-2025
- Processing Time Days
- 49
- Number Of Sites
- 5
- Number Of Participants
- 33
Sites
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Oncologie Medicale
- Principal Investigator Name
- Julien Mazieres
- Principal Investigator Email
- mazieres.julien@iuct-oncopole.fr
- Contact Person Name
- Julien Mazieres
- Contact Person Email
- mazieres.julien@iuct-oncopole.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Oncologie Medicale
- Principal Investigator Name
- Francois Ghiringhelli
- Principal Investigator Email
- fghiringhelli@cgfl.fr
- Contact Person Name
- Francois Ghiringhelli
- Contact Person Email
- fghiringhelli@cgfl.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Departement d’Innovation Therapeutique et des Essais Precoces (DITEP
- Principal Investigator Name
- Aranzazu Fernandez Martinez
- Principal Investigator Email
- aranzazu.fernandez-martinez@gustaveroussy.fr
- Contact Person Name
- Aranzazu Fernandez Martinez
- Contact Person Email
- aranzazu.fernandez-martinez@gustaveroussy.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Oncologie Medicale
- Principal Investigator Name
- Mario Campone
- Principal Investigator Email
- mario.campone@ico.unicancer.fr
- Contact Person Name
- Mario Campone
- Contact Person Email
- mario.campone@ico.unicancer.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Oncologie
- Principal Investigator Name
- Cecile Vicier
- Principal Investigator Email
- vicierc@ipc.unicancer.fr
- Contact Person Name
- Cecile Vicier
- Contact Person Email
- vicierc@ipc.unicancer.fr
Ireland
- Earliest CTIS Part Ii Submission Date
- 04-09-2025
- Latest Decision Or Authorization Date
- 12-09-2025
- Processing Time Days
- 8
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Mater Misericordiae University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Austin Duffy
- Principal Investigator Email
- austin.duffy@startdublin.com
- Contact Person Name
- Austin Duffy
- Contact Person Email
- austin.duffy@startdublin.com
- Site Name
- St Vincent's University Hospital
- Department Name
- Medical Oncology
- Principal Investigator Name
- Janice Walshe
- Principal Investigator Email
- janice.walshe@svhg.ie
- Contact Person Name
- Janice Walshe
- Contact Person Email
- janice.walshe@svhg.ie
- Site Name
- Cork University Hospital
- Department Name
- Cancer Research
- Principal Investigator Name
- Roisin Connolly
- Principal Investigator Email
- roisin.connolly5@hse.ie
- Contact Person Name
- Roisin Connolly
- Contact Person Email
- roisin.connolly5@hse.ie
Italy
- Earliest CTIS Part Ii Submission Date
- 05-09-2025
- Latest Decision Or Authorization Date
- 15-09-2025
- Processing Time Days
- 10
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Oncology
- Principal Investigator Name
- Erika Martinelli
- Principal Investigator Email
- erika.martinelli@unicampania.it
- Contact Person Name
- Erika Martinelli
- Contact Person Email
- erika.martinelli@unicampania.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Oncology
- Principal Investigator Name
- Salvatore Siena
- Principal Investigator Email
- salvatore.siena@unimi.it
- Contact Person Name
- Salvatore Siena
- Contact Person Email
- salvatore.siena@unimi.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Oncology
- Principal Investigator Name
- Lorenzo Antonuzzo
- Principal Investigator Email
- antonuzzol@aou-careggi.toscana.it
- Contact Person Name
- Lorenzo Antonuzzo
- Contact Person Email
- antonuzzol@aou-careggi.toscana.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Oncology
- Principal Investigator Name
- Giuseppe Curigliano
- Principal Investigator Email
- giuseppe.curigliano@ieo.it
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
Spain
- Earliest CTIS Part Ii Submission Date
- 05-09-2025
- Latest Decision Or Authorization Date
- 11-09-2025
- Processing Time Days
- 6
- Number Of Sites
- 7
- Number Of Participants
- 19
Sites
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Medical Oncology
- Principal Investigator Name
- Manuel Cobo Dols
- Principal Investigator Email
- manuelcobodols@yahoo.es
- Contact Person Name
- Manuel Cobo Dols
- Contact Person Email
- manuelcobodols@yahoo.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Valentina Gambardella
- Principal Investigator Email
- valen.gambardella@gmail.com
- Contact Person Name
- Valentina Gambardella
- Contact Person Email
- valen.gambardella@gmail.com
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Clinical Investigator Early Phase Trials Unit
- Principal Investigator Name
- Ramon Yarza Barrio
- Principal Investigator Email
- ramon.yarza@startmadrid.com
- Contact Person Name
- Ramon Yarza Barrio
- Contact Person Email
- ramon.yarza@startmadrid.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Principal Investigator Name
- Santiago Escriva de Romani Muñoz
- Principal Investigator Email
- sescriva@vhio.net
- Contact Person Name
- Santiago Escriva de Romani Muñoz
- Contact Person Email
- sescriva@vhio.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Manuel Ruiz Borrego
- Principal Investigator Email
- ruizsabater@gmail.com
- Contact Person Name
- Manuel Ruiz Borrego
- Contact Person Email
- ruizsabater@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Principal Investigator Name
- Eva Ciruelos Gil
- Principal Investigator Email
- eva.ciruelos@gmail.com
- Contact Person Name
- Eva Ciruelos Gil
- Contact Person Email
- eva.ciruelos@gmail.com
- Site Name
- Hospital Universitario Hm Sanchinarro (duplicate entry in source listing?)
- Department Name
- Clinical Investigator Early Phase Trials Unit
- Principal Investigator Name
- Ramon Yarza Barrio
- Principal Investigator Email
- ramon.yarza@startmadrid.com
- Contact Person Name
- Ramon Yarza Barrio
- Contact Person Email
- ramon.yarza@startmadrid.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 08-09-2025
- Latest Decision Or Authorization Date
- 12-09-2025
- Processing Time Days
- 4
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- NKI
- Department Name
- Clinical Research Unit (CRU)
- Principal Investigator Name
- Neeltje Steeghs
- Principal Investigator Email
- n.steeghs@nki.nl
- Contact Person Name
- Neeltje Steeghs
- Contact Person Email
- n.steeghs@nki.nl
Sponsor
Primary sponsor
- Full Name
- Iambic Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- IAM1363
- Modality
- Small molecule
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)