Clinical trial • Phase I • Oncology

DWJ155 (radiolabelled with gallium-68) for Breast cancer|Non-small cell lung cancer

Phase I trial of DWJ155 (radiolabelled with gallium-68) for Breast cancer|Non-small cell lung cancer. 36 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Breast cancer|Non-small cell lung cancer
Trial Stage
Phase I
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
28-04-2025
First CTIS Authorization Date
03-07-2025

Trial design

Phase I trial across 1 site in Netherlands.

Target Sample Size
36

Recruitment

Planned Sample Size
36
Recruitment Window Months
28

Geography

Total Number Of Sites
1
Total Number Of Participants
36

Netherlands

Earliest CTIS Part Ii Submission Date
03-06-2025
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
255
Number Of Sites
1
Number Of Participants
36

Sites

Site Name
Pharmaceutical Research Associates Group B.V.
Department Name
Program Management
Contact Person Name
Renger Tiessen
Contact Person Email
Renger.Tiessen@iconplc.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
Pharmaceutical Research Associates Group B.V.
Responsibilities
Program Management; contact person: Renger Tiessen (Renger.Tiessen@iconplc.com, +31504022386)

Investigational products

Investigational Product Name
[68Ga]Ga-DWJ155
Active Substance
DWJ155 (radiolabelled with gallium-68)
Modality
Radiopharmaceutical

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