Clinical trial • Phase I • Oncology
KQB198 for Advanced solid malignancies
Phase I trial of KQB198 for Advanced solid malignancies. 50 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid malignancies
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 13-05-2024
- First CTIS Authorization Date
- 29-08-2024
Trial design
Phase I trial across 25 sites in Italy, Spain, France.
- Target Sample Size
- 50
Eligibility
Recruits 50 Vulnerable population selected; no further details on consent or assent handling available in source..
- Vulnerable Population
- Vulnerable population selected; no further details on consent or assent handling available in source.
Recruitment
- Planned Sample Size
- 50
- Recruitment Window Months
- 35
- Consent Approach
- No information on consent or assent available in source.
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 112
Italy
- Earliest CTIS Part Ii Submission Date
- 06-08-2024
- Latest Decision Or Authorization Date
- 05-09-2025
- Processing Time Days
- 395
- Number Of Sites
- 8
- Number Of Participants
- 30
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- U.O.C. Phase 1
- Contact Person Name
- Gennaro Daniele
- Contact Person Email
- gennaro.daniele@policlinicogemelli.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- SC Oncologia Falck, Niguarda Cancer Center
- Contact Person Name
- Giulio Cerea
- Contact Person Email
- giulio.cerea@ospedaleniguarda.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- S.C. Oncologia
- Contact Person Name
- Francesco Agustoni
- Contact Person Email
- f.agustoni@smatteo.pv.it
- Site Name
- Centro Di Riferimento Oncologico Di Aviano
- Department Name
- S.O.C. Oncologia medica e dei tumori immuno-correlati
- Contact Person Name
- Alessandra Bearz
- Contact Person Email
- abearz@cro.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- U.O. Oncologia Medica
- Contact Person Name
- Gianluca Del Conte
- Contact Person Email
- delconte.gianluca@hsr.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Ricerca Traslazionale a Servizio dei Percorsi Oncologici
- Contact Person Name
- Adriano Gravina
- Contact Person Email
- a.gravina@istitutotumori.na.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative
- Contact Person Name
- Giuseppe Curigliano
- Contact Person Email
- giuseppe.curigliano@ieo.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- U.O. Oncologia, Dipartimento Onco-Ematologico
- Contact Person Name
- Manolo D'Arcangelo
- Contact Person Email
- manolo.darcangelo@auslromagna.it
Spain
- Earliest CTIS Part Ii Submission Date
- 24-06-2024
- Latest Decision Or Authorization Date
- 12-08-2025
- Processing Time Days
- 414
- Number Of Sites
- 10
- Number Of Participants
- 40
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Contact Person Name
- Ramon Yarza
- Contact Person Email
- Ramon.Yarza@startmadrid.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Contact Person Name
- Anna Vilalta Lacarra
- Contact Person Email
- avilaltal@unav.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Nuria Pardo Aranda
- Contact Person Email
- npardo@vhio.net
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- Oncology
- Contact Person Name
- Elena Garralda Cabanas
- Contact Person Email
- e.garralda@nextoncology.eu
- Site Name
- Hospital Hm Nou Delfos
- Department Name
- Oncology
- Contact Person Name
- Tatiana Hernandez Guerrero
- Contact Person Email
- tatiana.hernandez@start-barcelona.com
- Site Name
- Hospital Quironsalud Malaga
- Department Name
- Oncology
- Contact Person Name
- Manuel Cobo Dols
- Contact Person Email
- manuelcobodols@yahoo.es
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Oncology
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Contact Person Name
- Victor Moreno Garcia
- Contact Person Email
- victor.moreno@startmadrid.com
- Site Name
- Hospital Universitari Dexeus Grupo Quironsalud
- Department Name
- Oncology
- Contact Person Name
- Andres Aguilar Hernandez
- Contact Person Email
- aaguilar@oncorosell.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Contact Person Name
- Pilar Garrido Lopez
- Contact Person Email
- pilargarridol@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 04-07-2024
- Latest Decision Or Authorization Date
- 09-01-2026
- Processing Time Days
- 554
- Number Of Sites
- 7
- Number Of Participants
- 42
Sites
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Oncologie Médical
- Contact Person Name
- Audrey RABEAU
- Contact Person Email
- rabeau.audrey@iuct-oncopole.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Oncologie Médical
- Contact Person Name
- Amaury DASTE
- Contact Person Email
- amaury.daste@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Oncologie thoracique
- Contact Person Name
- Jeanne CHEN
- Contact Person Email
- jeanne.chen@chu-nantes.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Oncologie Médical
- Contact Person Name
- Judith Raimbourg
- Contact Person Email
- judith.raimbourg@ico.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie Médical
- Contact Person Name
- Maurice PEROL
- Contact Person Email
- maurice.perol@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Oncologie thoracique
- Contact Person Name
- Denis MORO-SIBILOT
- Contact Person Email
- DMoro-Sibilot@chu-grenoble.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Oncologie Médical
- Contact Person Name
- Cecile VICIER
- Contact Person Email
- VICIERC@ipc.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Kumquat Biosciences Inc.
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- KQB198
- Combination Treatment
- Yes
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