Clinical trial • Phase I • Oncology

Pembrolizumab for HER2-expressing advanced or metastatic cancers

Phase I trial of Pembrolizumab for HER2-expressing advanced or metastatic cancers. 405 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
HER2-expressing advanced or metastatic cancers
Trial Stage
Phase I
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
23-07-2024
First CTIS Authorization Date
27-08-2024

Trial design

Phase I trial across 10 sites in Spain, France, Portugal.

Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
405

Recruitment

Planned Sample Size
405
Recruitment Window Months
64

Geography

Total Number Of Sites
10
Total Number Of Participants
240

Spain

Earliest CTIS Part Ii Submission Date
15-07-2024
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
576
Number Of Sites
6
Number Of Participants
150

Sites

Site Name
Hospital Quironsalud Barcelona
Department Name
Unidad de Ensayos Fase I
Contact Person Name
Guzman Alonso Casal
Contact Person Email
galonso@nextoncology.eu
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
NEXT Oncology Madrid
Contact Person Name
Valentina Boni
Contact Person Email
vboni@nextoncology.eu
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Jose Maria Lopez Picazo
Contact Person Email
jlpicazo@unav.es
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Jose Maria Lopez Picazo
Contact Person Email
jlpicazo@unav.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Elena Garralda Cabanas
Contact Person Email
egarralda@vhio.net
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Unidad Fases I Star
Contact Person Name
Ramón Yarza
Contact Person Email
ramon.yarza@startmadrid.com

France

Earliest CTIS Part Ii Submission Date
15-07-2024
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
571
Number Of Sites
3
Number Of Participants
50

Sites

Site Name
Oncopole Claudius Regaud
Department Name
Medical Oncology
Contact Person Name
Carlos Alberto Gomez-Roca
Site Name
Institut Gustave Roussy
Department Name
Département d'Innovation Thérapeutique et des Essais Précoces (DITEP)
Contact Person Name
Rastislav Bahleda
Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical Oncology
Contact Person Name
Marie Robert
Contact Person Email
marie.robert@ico.unicancer.fr

Portugal

Earliest CTIS Part Ii Submission Date
15-07-2024
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
575
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Serviço de Oncologia Médica
Contact Person Name
Júlio Oliveira

Sponsor

Primary sponsor

Full Name
Vir Biotechnology Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
VIR-5818
Modality
Monoclonal antibody
First In Human
Yes
Investigational Product Name
Pembrolizumab
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Combination Treatment
Yes

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