Clinical trial • Phase I • Oncology

REGN5054 for Advanced solid tumor

Phase I trial of REGN5054 for Advanced solid tumor. None/Not specified-controlled. 40 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced solid tumor
Trial Stage
Phase I
Drug Modality
Radiopharmaceutical | Monoclonal antibody

Key dates

Initial CTIS Submission Date
30-08-2024
First CTIS Authorization Date
17-09-2024

Trial design

None/Not specified-controlled Phase I trial across 1 site in Netherlands.

Comparator
None/Not specified
Target Sample Size
40

Recruitment

Planned Sample Size
40
Recruitment Window Months
55

Geography

Total Number Of Sites
1
Total Number Of Participants
40

Netherlands

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
10-03-2025
Processing Time Days
182
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Medical Oncology
Principal Investigator Name
Elisabeth de Vries
Principal Investigator Email
e.g.e.de.vries@umcg.nl
Contact Person Name
Elisabeth de Vries
Contact Person Email
e.g.e.de.vries@umcg.nl

Sponsor

Primary sponsor

Full Name
Regeneron Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
89Zr-DFO-REGN5054
Active Substance
REGN5054
Modality
Radiopharmaceutical | Monoclonal antibody
Combination Treatment
Yes

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