Clinical trial • Phase I • Oncology
RMC-6291 for Non-small cell lung cancer | Pancreatic ductal adenocarcinoma | Advanced solid tumor | Colorectal cancer
Phase I trial of RMC-6291 for Non-small cell lung cancer | Pancreatic ductal adenocarcinoma | Advanced solid tumor | Colorectal cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer | Pancreatic ductal adenocarcinoma | Advanced solid tumor | Colorectal cancer
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 20-02-2024
- First CTIS Authorization Date
- 01-04-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase I trial across 27 sites in Czechia, Poland, Italy and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, dose escalation and dose expansion design (specific escalation rules, interim analyses or stopping rules not specified in provided data)
- Biomarker Stratified
- True, biomarker: KRAS G12C mutation (KRASG12C)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 118
Recruitment
- Planned Sample Size
- 118
- Recruitment Window Months
- 49
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 104
Czechia
- Earliest CTIS Part Ii Submission Date
- 06-03-2024
- Latest Decision Or Authorization Date
- 25-09-2024
- Processing Time Days
- 203
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- University Hospital Olomouc
- Department Name
- Department of Oncology
- Principal Investigator Name
- Bohuslav Melichar
- Principal Investigator Email
- bohuslav.melichar@fnol.cz
- Contact Person Name
- Bohuslav Melichar
- Contact Person Email
- bohuslav.melichar@fnol.cz
- Site Name
- Multiscan s.r.o.
- Department Name
- Oncological Care Center
- Principal Investigator Name
- Martin Smakal
- Principal Investigator Email
- msmakal@gmail.com
- Contact Person Name
- Martin Smakal
- Contact Person Email
- msmakal@gmail.com
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Department of Oncology and Radiotherapy
- Principal Investigator Name
- Stanislav John
- Principal Investigator Email
- stanislav.john@fnhk.cz
- Contact Person Name
- Stanislav John
- Contact Person Email
- stanislav.john@fnhk.cz
Poland
- Earliest CTIS Part Ii Submission Date
- 06-03-2024
- Latest Decision Or Authorization Date
- 16-10-2024
- Processing Time Days
- 224
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Instytut Msf Sp. z o.o.
- Department Name
- Department of Oncology
- Principal Investigator Name
- Ewa Kalinka
- Principal Investigator Email
- ewakalinka@wp.pl
- Contact Person Name
- Ewa Kalinka
- Contact Person Email
- ewakalinka@wp.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Early Phase Clinical Trials Unit and Department of Soft Tissue/Bone Sarcoma and Melanoma
- Principal Investigator Name
- Iwona Lugowska
- Principal Investigator Email
- iwona.lugowska@pib-nio.pl
- Contact Person Name
- Iwona Lugowska
- Contact Person Email
- iwona.lugowska@pib-nio.pl
- Site Name
- Med Polonia Sp. z o.o.
- Department Name
- Oncology
- Principal Investigator Name
- Rodryg Ramlau
- Principal Investigator Email
- rramlau@gmail.com
- Contact Person Name
- Rodryg Ramlau
- Contact Person Email
- rramlau@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 06-03-2024
- Latest Decision Or Authorization Date
- 27-09-2024
- Processing Time Days
- 205
- Number Of Sites
- 6
- Number Of Participants
- 16
Sites
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Research Center Oncology
- Principal Investigator Name
- Andrea Zivi
- Principal Investigator Email
- andrea.zivi@aovr.veneto.it
- Contact Person Name
- Andrea Zivi
- Contact Person Email
- andrea.zivi@aovr.veneto.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Medical Oncology
- Principal Investigator Name
- Silvia Novello
- Principal Investigator Email
- silvia.novello@unito.it
- Contact Person Name
- Silvia Novello
- Contact Person Email
- silvia.novello@unito.it
- Site Name
- European Institute Of Oncology S.r.l.
- Department Name
- Division of New Drug Development for Innovative Therapies
- Principal Investigator Name
- Giuseppe Curigliano
- Principal Investigator Email
- giuseppe.curigliano@ieo.it
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Experimental Clinical Oncology Melanoma Immunotherapy and Innovative Therapies
- Principal Investigator Name
- Paolo Antonio Ascierto
- Principal Investigator Email
- p.ascierto@istitutotumori.na.it
- Contact Person Name
- Paolo Antonio Ascierto
- Contact Person Email
- p.ascierto@istitutotumori.na.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- Medical Sciences and Infectious Disease Dep.
- Principal Investigator Name
- Francesco Agustoni
- Principal Investigator Email
- f.agustoni@smatteo.pv.it
- Contact Person Name
- Francesco Agustoni
- Contact Person Email
- f.agustoni@smatteo.pv.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Hematology and Oncology
- Principal Investigator Name
- Alessio Amatu
- Principal Investigator Email
- alessio.amatu@ospedaleniguarda.it
- Contact Person Name
- Alessio Amatu
- Contact Person Email
- alessio.amatu@ospedaleniguarda.it
Spain
- Earliest CTIS Part Ii Submission Date
- 06-03-2024
- Latest Decision Or Authorization Date
- 24-09-2024
- Processing Time Days
- 202
- Number Of Sites
- 8
- Number Of Participants
- 30
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Bernard Doger de Spéville
- Principal Investigator Email
- bernard.doger@startmadrid.com
- Contact Person Name
- Bernard Doger de Spéville
- Contact Person Email
- bernard.doger@startmadrid.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Ruffinelli Rodriguez Jose Carlos
- Principal Investigator Email
- nmulet@iconcologia.net
- Contact Person Name
- Ruffinelli Rodriguez Jose Carlos
- Contact Person Email
- nmulet@iconcologia.net
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Reyes Bernabe Caro
- Principal Investigator Email
- reyesbernab@yahoo.es
- Contact Person Name
- Reyes Bernabe Caro
- Contact Person Email
- reyesbernab@yahoo.es
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Principal Investigator Name
- Valentina Boni
- Principal Investigator Email
- vboni@nextoncology.eu
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Principal Investigator Name
- Mariano Ponz-Sarvise
- Principal Investigator Email
- mponz@unav.es
- Contact Person Name
- Mariano Ponz-Sarvise
- Contact Person Email
- mponz@unav.es
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- Oncology
- Principal Investigator Name
- Elena Garralda
- Principal Investigator Email
- egerralda@nextoncology.eu
- Contact Person Name
- Elena Garralda
- Contact Person Email
- egerralda@nextoncology.eu
- Site Name
- MD Anderson Cancer Center
- Department Name
- Medical oncology
- Principal Investigator Name
- Fernando Fabio Franco Perez
- Principal Investigator Email
- ffranco@fundacionmdanderson.es
- Contact Person Name
- Fernando Fabio Franco Perez
- Contact Person Email
- ffranco@fundacionmdanderson.es
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Oncology service
- Principal Investigator Name
- Ángel Artal Cortes
- Principal Investigator Email
- aartalc@salud.aragon.es
- Contact Person Name
- Ángel Artal Cortes
- Contact Person Email
- aartalc@salud.aragon.es
Sponsor
Primary sponsor
- Full Name
- Revolution Medicines Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- RMC-6291
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