Clinical trial • Phase III • Oncology

KQB198 for Advanced hematologic malignancies | Hematological malignancy

Phase III trial of KQB198 for Advanced hematologic malignancies | Hematological malignancy. 60 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced hematologic malignancies | Hematological malignancy
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
05-09-2024
First CTIS Authorization Date
15-01-2025

Trial design

Phase III trial across 18 sites in France, Germany, Spain and others.

Target Sample Size
60
Trial Duration For Participant
1064

Eligibility

Recruits 60 Vulnerable population not selected; no consent or assent handling information provided..

Vulnerable Population
Vulnerable population not selected; no consent or assent handling information provided.

Recruitment

Planned Sample Size
60
Recruitment Window Months
35
Consent Approach
No information provided on informed consent or assent; no age-specific consent documents or languages specified.

Geography

Total Number Of Sites
18
Total Number Of Participants
69

France

Earliest CTIS Part Ii Submission Date
16-10-2024
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
460
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Centre Leon Berard
Department Name
Medical oncology
Principal Investigator Name
Franck Nicolini
Principal Investigator Email
Franck-Emmanuel.NICOLINI@lyon.unicancer.fr
Contact Person Name
Franck Nicolini
Site Name
CHU de Tours - Hopital Bretonneau
Department Name
Hematology
Principal Investigator Name
Antoine MACHET
Principal Investigator Email
a.machet@chu-tours.fr
Contact Person Name
Antoine MACHET
Contact Person Email
a.machet@chu-tours.fr
Site Name
Hôpital de la Timone
Department Name
Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM)
Principal Investigator Name
Regis Costello
Principal Investigator Email
Regis.COSTELLO@ap-hm.fr
Contact Person Name
Regis Costello
Contact Person Email
Regis.COSTELLO@ap-hm.fr

Germany

Earliest CTIS Part Ii Submission Date
21-11-2024
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
426
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Universitaetsklinikum Jena KöR
Department Name
Hematology and internal Oncology
Principal Investigator Name
Andreas Hochhaus
Principal Investigator Email
Andreas.Hochhaus@med.uni-jena.de
Contact Person Name
Andreas Hochhaus
Site Name
Medizinische Hochschule Hannover
Department Name
Hematology, Hemostasis, Oncology and Stem Cell Transplantation
Principal Investigator Name
Susanne Isfort
Principal Investigator Email
isfort.susanne@mh-hannover.de
Contact Person Name
Susanne Isfort
Contact Person Email
isfort.susanne@mh-hannover.de

Spain

Earliest CTIS Part Ii Submission Date
08-11-2024
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
441
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Hospital Universitario Regional De Malaga
Department Name
Hematology and Hemotherapy
Principal Investigator Name
Maria Concepcion Ruiz Nuno
Principal Investigator Email
conchirn@hotmail.com
Contact Person Name
Maria Concepcion Ruiz Nuno
Contact Person Email
conchirn@hotmail.com
Site Name
Hospital Universitario La Paz
Department Name
Hematology and Hemotherapy
Principal Investigator Name
Raquel De Paz Arias
Principal Investigator Email
depazraquel@gmail.com
Contact Person Name
Raquel De Paz Arias
Contact Person Email
depazraquel@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Hematology
Principal Investigator Name
Jasson Villarreal Hernández
Principal Investigator Email
jvillarreal@iconcologia.net
Contact Person Name
Jasson Villarreal Hernández
Contact Person Email
jvillarreal@iconcologia.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Principal Investigator Name
Joaquin Martinez Lopez
Principal Investigator Email
jmarti01@med.ucm.es
Contact Person Name
Joaquin Martinez Lopez
Contact Person Email
jmarti01@med.ucm.es

Poland

Earliest CTIS Part Ii Submission Date
02-12-2024
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
420
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Aidport Sp. z o.o.
Department Name
AIDPORT SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
Principal Investigator Name
Michał Kwiatek
Principal Investigator Email
michal.kwiatek@aidport.pl
Contact Person Name
Michał Kwiatek
Contact Person Email
michal.kwiatek@aidport.pl
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Principal Investigator Name
Sebastian Grosicki
Principal Investigator Email
sgrosicki@wp.pl
Contact Person Name
Sebastian Grosicki
Contact Person Email
sgrosicki@wp.pl
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Wojewódzkie Centrum Onkologii
Principal Investigator Name
Hanna Ciepłuch
Principal Investigator Email
ciepluch@gumed.edu.pl
Contact Person Name
Hanna Ciepłuch
Contact Person Email
ciepluch@gumed.edu.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii
Principal Investigator Name
Witold Prejzner
Principal Investigator Email
wpre@gumed.edu.pl
Contact Person Name
Witold Prejzner
Contact Person Email
wpre@gumed.edu.pl

Italy

Earliest CTIS Part Ii Submission Date
27-11-2024
Latest Decision Or Authorization Date
25-02-2026
Processing Time Days
455
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Ematologia
Principal Investigator Name
Fausto Castagnetti
Principal Investigator Email
fausto.castagnetti@unibo.it
Contact Person Name
Fausto Castagnetti
Contact Person Email
fausto.castagnetti@unibo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
DIAGNOSTICA PER IMMAGINI, RADIOTERAPIA ONCOLOGICA ED EMATOLOGIA
Principal Investigator Name
Federica Sorà
Principal Investigator Email
FEDERICA.SORA@UNICATT.IT
Contact Person Name
Federica Sorà
Contact Person Email
FEDERICA.SORA@UNICATT.IT
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Ematologia
Principal Investigator Name
Marianna Caramella
Principal Investigator Email
marianna.caramella@ospedaleniguarda.it
Contact Person Name
Marianna Caramella
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Ematologia
Principal Investigator Name
Alessandra Iurlo
Principal Investigator Email
alessandra.iurlo@policlinico.mi.it
Contact Person Name
Alessandra Iurlo

Netherlands

Earliest CTIS Part Ii Submission Date
27-03-2025
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
299
Number Of Sites
1
Number Of Participants
9

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Department of Hematology
Principal Investigator Name
Jeroen Janssen
Principal Investigator Email
jeroen.janssen1@radboudumc.nl
Contact Person Name
Jeroen Janssen
Contact Person Email
jeroen.janssen1@radboudumc.nl

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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