Clinical trial • Phase I • Oncology

DFC413 labelled with lutetium-177 for Colorectal cancer | Pancreatic ductal adenocarcinoma | Non-small cell lung cancer | Soft tissue sarcoma | HR+/HER2- breast cancer | Triple-negative breast cancer

Phase I trial of DFC413 labelled with lutetium-177 for Colorectal cancer | Pancreatic ductal adenocarcinoma | Non-small cell lung cancer | Soft tissue sar…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Colorectal cancer | Pancreatic ductal adenocarcinoma | Non-small cell lung cancer | Soft tissue sarcoma | HR+/HER2- breast cancer | Triple-negative breast cancer
Trial Stage
Phase I
Drug Modality
Radiopharmaceutical | Diagnostic agent

Key dates

Initial CTIS Submission Date
15-10-2025
First CTIS Authorization Date
16-02-2026

Trial design

open-label Phase I trial across 10 sites in Denmark, Portugal, Germany and others.

Open Label
Yes
Target Sample Size
83

Recruitment

Planned Sample Size
83
Recruitment Window Months
39

Geography

Total Number Of Sites
10
Total Number Of Participants
62

Denmark

Earliest CTIS Part Ii Submission Date
23-01-2026
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
24
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Odense University Hospital
Department Name
1100, Onkologisk Afdeling R
Contact Person Name
Annette Kodahl
Contact Person Email
annette.kodahl@rsyd.dk
Site Name
Rigshospitalet
Department Name
1101, Onkologisk Afd.
Contact Person Name
Kristoffer Stall Rohrberg

Portugal

Earliest CTIS Part Ii Submission Date
12-12-2025
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
70
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
1500 : Oncologia Médica
Contact Person Name
Sara Pinto Coelho

Germany

Earliest CTIS Part Ii Submission Date
03-02-2026
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
16
Number Of Sites
1
Number Of Participants
9

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
1300: Klinik für Nuklearmedizin
Contact Person Name
Ken Herrmann
Contact Person Email
Ken.herrmann@uk-essen.de

France

Earliest CTIS Part Ii Submission Date
02-12-2025
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
76
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Institut Paoli Calmettes
Department Name
1202 Medical Oncology
Contact Person Name
Cecile VICIER
Contact Person Email
vicierc@ipc.unicancer.fr
Site Name
Oncopole Claudius Regaud
Department Name
1203 Nuclear Medicine
Contact Person Name
Frederic COURBON
Site Name
Centre Leon Berard
Department Name
1201 Medical Oncology
Contact Person Name
Philippe CASSIER
Site Name
CHRU De Nancy
Department Name
1200 Nuclear Medicine
Contact Person Name
Caroline BOURSIER
Contact Person Email
c.boursier@chru-nancy.fr

Spain

Earliest CTIS Part Ii Submission Date
05-11-2025
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
105
Number Of Sites
2
Number Of Participants
18

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
1601 Oncology
Contact Person Name
Maria Vieito Villar
Contact Person Email
mvieito@vhio.net
Site Name
Institut Catala D'oncologia
Department Name
1600 Oncology
Contact Person Name
Marta Gil Martin
Contact Person Email
mgilmartin@iconcologia.net

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
[177Lu]Lu-DFC413
Active Substance
DFC413 labelled with lutetium-177
Modality
Radiopharmaceutical
Investigational Product Name
[68Ga]Ga-NNS309
Active Substance
NNS309 labelled with gallium-68
Modality
Diagnostic agent

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