Clinical trial • Phase I • Oncology
AMG 436 for Microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) solid tumors
Phase I trial of AMG 436 for Microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) solid tumors. None/Not specified-controlled.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) solid tumors
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 15-01-2026
- First CTIS Authorization Date
- 28-04-2026
Trial design
None/Not specified-controlled Phase I trial in Belgium, Spain, France.
- Comparator
- None/Not specified
- Target Sample Size
- 387
Eligibility
Recruits 387 Vulnerable populations selected; no further details on consent or assent handling available..
- Vulnerable Population
- Vulnerable populations selected; no further details on consent or assent handling available.
Recruitment
- Planned Sample Size
- 387
- Recruitment Window Months
- 71
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 77
Belgium
- Earliest CTIS Part Ii Submission Date
- 24-03-2026
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 36
- Number Of Sites
- 4
- Number Of Participants
- 17
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Oncology
- Principal Investigator Name
- Rachel Galot
- Principal Investigator Email
- rachel.galot@saintluc.uclouvain.be
- Contact Person Name
- Rachel Galot
- Contact Person Email
- rachel.galot@saintluc.uclouvain.be
- Site Name
- UZ Leuven
- Department Name
- Digestive Oncology
- Principal Investigator Name
- Jeroen Dekervel
- Principal Investigator Email
- jeroen.dekervel@uzleuven.be
- Contact Person Name
- Jeroen Dekervel
- Contact Person Email
- jeroen.dekervel@uzleuven.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Oncology
- Principal Investigator Name
- Hans Prenen
- Principal Investigator Email
- hans.prenen@uza.be
- Contact Person Name
- Hans Prenen
- Contact Person Email
- hans.prenen@uza.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sylvie Rottey
- Principal Investigator Email
- Sylvie.Rottey@uzgent.be
- Contact Person Name
- Sylvie Rottey
- Contact Person Email
- Sylvie.Rottey@uzgent.be
Spain
- Earliest CTIS Part Ii Submission Date
- 15-04-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 19
- Number Of Sites
- 10
- Number Of Participants
- 30
Sites
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Servicio de Hematologia y Oncologia
- Principal Investigator Name
- Desamparados Roda Perez
- Principal Investigator Email
- derope@hotmail.com
- Contact Person Name
- Desamparados Roda Perez
- Contact Person Email
- derope@hotmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Rocio Garcia Carbonero
- Principal Investigator Email
- rgcarbonero.ensayos@gmail.com
- Contact Person Name
- Rocio Garcia Carbonero
- Contact Person Email
- rgcarbonero.ensayos@gmail.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Servicio de Oncologia Medica
- Principal Investigator Name
- Ignacio Matos Garcia
- Principal Investigator Email
- imatos@unav.es
- Contact Person Name
- Ignacio Matos Garcia
- Contact Person Email
- imatos@unav.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Servicio de Oncologia Medica
- Principal Investigator Name
- Fernando Rivera Herrero
- Principal Investigator Email
- fernando.rivera@scsalud.es
- Contact Person Name
- Fernando Rivera Herrero
- Contact Person Email
- fernando.rivera@scsalud.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Servicio de Oncologia Medica
- Principal Investigator Name
- Pilar Aitana Calvo Ferrandiz
- Principal Investigator Email
- aitanacalvo@hotmail.com
- Contact Person Name
- Pilar Aitana Calvo Ferrandiz
- Contact Person Email
- aitanacalvo@hotmail.com
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Servicio de Oncologia Medica
- Principal Investigator Name
- Manuel Fernandez Bruno
- Principal Investigator Email
- manuel.fernandez.bruno@sergas.es
- Contact Person Name
- Manuel Fernandez Bruno
- Contact Person Email
- manuel.fernandez.bruno@sergas.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Elena Garralda Cabanas
- Principal Investigator Email
- egarralda@vhio.net
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- egarralda@vhio.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Servicio de Oncologia Medica
- Principal Investigator Name
- Ivan Manuel Victoria Ruiz
- Principal Investigator Email
- ivictori@recerca.clinic.cat
- Contact Person Name
- Ivan Manuel Victoria Ruiz
- Contact Person Email
- ivictori@recerca.clinic.cat
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Servicio de Oncologia Medica
- Principal Investigator Name
- Encarnacion Gonzalez Flores
- Principal Investigator Email
- encarnagonzalezflores@gmail.com
- Contact Person Name
- Encarnacion Gonzalez Flores
- Contact Person Email
- encarnagonzalezflores@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Servicio de Oncologia
- Principal Investigator Name
- Javier Blanco Avila
- Principal Investigator Email
- javier.blanco@ibima.eu
- Contact Person Name
- Javier Blanco Avila
- Contact Person Email
- javier.blanco@ibima.eu
France
- Earliest CTIS Part Ii Submission Date
- 26-02-2026
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 61
- Number Of Sites
- 8
- Number Of Participants
- 30
Sites
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Philippe CASSIER
- Principal Investigator Email
- philippe.cassier@lyon.unicancer.fr
- Contact Person Name
- Philippe CASSIER
- Contact Person Email
- philippe.cassier@lyon.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Medical Oncology
- Principal Investigator Name
- Julien TAIEB
- Principal Investigator Email
- julien.taieb@aphp.fr
- Contact Person Name
- Julien TAIEB
- Contact Person Email
- julien.taieb@aphp.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Oncology
- Principal Investigator Name
- Cécile VICIER
- Principal Investigator Email
- vicierc@ipc.unicancer.fr
- Contact Person Name
- Cécile VICIER
- Contact Person Email
- vicierc@ipc.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- DITEP
- Principal Investigator Name
- Antoine HOLLEBECQUE
- Principal Investigator Email
- antoine.hollebecque@gustaveroussy.fr
- Contact Person Name
- Antoine HOLLEBECQUE
- Contact Person Email
- antoine.hollebecque@gustaveroussy.fr
- Site Name
- Hopital Saint Antoine
- Department Name
- Oncology
- Principal Investigator Name
- Thierry ANDRE
- Principal Investigator Email
- thierry.andre@aphp.fr
- Contact Person Name
- Thierry ANDRE
- Contact Person Email
- thierry.andre@aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Benoît YOU
- Principal Investigator Email
- benoit.you@chu-lyon.fr
- Contact Person Name
- Benoît YOU
- Contact Person Email
- benoit.you@chu-lyon.fr
- Site Name
- Centr Georges Francois Leclerc
- Department Name
- Medical Oncology
- Principal Investigator Name
- François GHIRINGHELLI
- Principal Investigator Email
- fghiringhelli@cgfl.fr
- Contact Person Name
- François GHIRINGHELLI
- Contact Person Email
- fghiringhelli@cgfl.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Medical Oncology - Gastroenterology and Urology
- Principal Investigator Name
- Aurélien CARNOT
- Principal Investigator Email
- a-carnot@o-lambret.fr
- Contact Person Name
- Aurélien CARNOT
- Contact Person Email
- a-carnot@o-lambret.fr
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- AMG 436
- Combination Treatment
- Yes
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