Clinical trial • Phase I • Oncology

CK-301 for Cutaneous squamous cell carcinoma (unresectable or metastatic)

Phase I trial of CK-301 for Cutaneous squamous cell carcinoma (unresectable or metastatic). open-label, none/not specified-controlled, adaptive.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Cutaneous squamous cell carcinoma (unresectable or metastatic)
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
06-09-2024
First CTIS Authorization Date
24-09-2024

Trial design

open-label, none/not specified-controlled, adaptive Phase I trial across 10 sites in Spain, France.

Open Label
Yes
Comparator
None/Not specified
Adaptive
True - dose-escalation design; escalation of CK-301 doses; no specific escalation algorithm, dose levels, or stopping rules provided in source.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
357

Eligibility

Recruits 357 Vulnerable population selected; no details on consent or assent handling provided in source..

Vulnerable Population
Vulnerable population selected; no details on consent or assent handling provided in source.

Recruitment

Planned Sample Size
357
Recruitment Window Months
88

Geography

Total Number Of Sites
10
Total Number Of Participants
63

Spain

Earliest CTIS Part Ii Submission Date
26-08-2024
Latest Decision Or Authorization Date
24-09-2024
Processing Time Days
29
Number Of Sites
4
Number Of Participants
29

Sites

Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology
Contact Person Name
María Carmen Álamo de Gala
Contact Person Email
alamodelagala@gmail.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Contact Person Name
Ricardo Yaya
Contact Person Email
ryaya@fivo.org
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Eva Muñoz
Contact Person Email
emunoz@vhio.net
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Contact Person Name
Miguel Angel Berciano
Contact Person Email
migueberci@gmail.com

France

Earliest CTIS Part Ii Submission Date
26-08-2024
Latest Decision Or Authorization Date
13-11-2024
Processing Time Days
79
Number Of Sites
6
Number Of Participants
34

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Onco-Dermatology
Contact Person Name
Gaëlle Quereux
Contact Person Email
gaelle.quereux@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Onco-Dermatology
Contact Person Name
Julie Charles
Contact Person Email
jcharles@chugrenoble.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Onco-Dermatology
Contact Person Name
Henri Montaudié
Contact Person Email
montaudie.h@chu-nice.fr
Site Name
CHU Besancon
Department Name
Onco-Dermatology
Contact Person Name
Charlee Nardin
Contact Person Email
cnardin@chu-besancon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Onco-Dermatology
Contact Person Name
Marie Beylot-Barry
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Onco-Dermatology

Sponsor

Primary sponsor

Full Name
Checkpoint Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
CK-301
Routes Of Administration
Intravenous
Route
Intravenous

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