Clinical trial • Phase I • Oncology

KO-2806 for Pancreatic ductal adenocarcinoma | Colorectal cancer | Non-small cell lung cancer | Renal cell carcinoma

Phase I trial of KO-2806 for Pancreatic ductal adenocarcinoma | Colorectal cancer | Non-small cell lung cancer | Renal cell carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Pancreatic ductal adenocarcinoma | Colorectal cancer | Non-small cell lung cancer | Renal cell carcinoma
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
30-09-2024
First CTIS Authorization Date
30-01-2025

Trial design

None/Not specified-controlled Phase I trial across 16 sites in France, Germany, Italy and others.

Comparator
None/Not specified
Target Sample Size
234

Eligibility

Recruits 234 Vulnerable population selected; no details on consent or assent available in the provided documents..

Vulnerable Population
Vulnerable population selected; no details on consent or assent available in the provided documents.

Recruitment

Planned Sample Size
234
Recruitment Window Months
35
Consent Approach
No information on informed consent or assent process available in provided documents.

Geography

Total Number Of Sites
16
Total Number Of Participants
66

France

Earliest CTIS Part Ii Submission Date
21-01-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
454
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncologie Médicale
Contact Person Name
Paul GOUGIS
Contact Person Email
Paul.gougis@aphp.fr
Site Name
Oncopole Claudius Regaud
Department Name
Oncologie Médicale
Contact Person Name
Audrey RABEAU
Contact Person Email
Rabeau.audrey@iuct-oncopole.fr
Site Name
Centre Leon Berard
Department Name
Oncologie Médicale
Contact Person Name
Philippe CASSIER
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncologie Médicale
Contact Person Name
Jacques MEDIONI
Contact Person Email
Jacques.medioni@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
07-01-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
427
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Interdisziplinäres Studienzentrum
Contact Person Name
Barbara Deschler-Baier
Contact Person Email
ISZ_Koordination@ukw.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Med. Klinik m.S. Hämato-Onkologie
Contact Person Name
Sebastian Ochsenreither
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Comprehensive Cancer Center Ulm (CCCU) – Early Clinical Trials Unit (ECTU)
Contact Person Name
Friedemann Zengerling

Italy

Earliest CTIS Part Ii Submission Date
07-01-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
426
Number Of Sites
5
Number Of Participants
27

Sites

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 Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
SC Oncology
Contact Person Name
Vanessa Gregorc
Contact Person Email
vanesa.gregorc@ircc.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Oncology and Haematology
Contact Person Name
Stefania Salvagni
Contact Person Email
stefania.salvagni@aosp.bo.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
U.O di Oncologia Medica ed Ematologia
Contact Person Name
Agnese Losurdo
Contact Person Email
agnese.losurdo@humanitas.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Oncology Section
Contact Person Name
Andrea Zivi
Contact Person Email
andrea.zivi@aovr.veneto.it

Spain

Earliest CTIS Part Ii Submission Date
07-01-2025
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
433
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Elena Garralda Cabanas
Contact Person Email
egarralda@vhio.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Alejandro Falcón González
Contact Person Email
afalconglez@gmail.com
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Contact Person Name
Ramon Yarza Barrio
Contact Person Email
ramon.yarza@startmadrid.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Contact Person Name
Geórgia Anguera Palacios
Contact Person Email
ganguera@santpau.cat

Sponsor

Primary sponsor

Full Name
Kura Oncology Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
KO-2806
Combination Treatment
Yes

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