Clinical trial • Phase I • Oncology

IAG933 for Mesothelioma | Other solid tumours with Hippo pathway alterations

Phase I trial of IAG933 for Mesothelioma | Other solid tumours with Hippo pathway alterations. 62 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Mesothelioma | Other solid tumours with Hippo pathway alterations
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
20-12-2023
First CTIS Authorization Date
20-02-2024

Trial design

Phase I trial across 6 sites in Netherlands, France, Spain and others.

Biomarker Stratified
True, biomarker: Hippo pathway molecular alterations
Target Sample Size
62

Eligibility

Recruits 62 Vulnerable population selected; no details on consent or assent available..

Vulnerable Population
Vulnerable population selected; no details on consent or assent available.

Recruitment

Planned Sample Size
62
Recruitment Window Months
59

Geography

Total Number Of Sites
6
Total Number Of Participants
89

Netherlands

Latest Decision Or Authorization Date
20-02-2024
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
7001: Pulmonary Department
Principal Investigator Name
Joachim Aerts
Principal Investigator Email
j.aerts@erasmusmc.nl
Contact Person Name
Joachim Aerts
Contact Person Email
j.aerts@erasmusmc.nl

France

Latest Decision Or Authorization Date
26-02-2024
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Institut Gustave Roussy
Department Name
4001: Innovations Thérapeutiques et Essais Précoces
Principal Investigator Name
Christophe MASSARD
Principal Investigator Email
Christophe.MASSARD@gustaveroussy.fr
Contact Person Name
Christophe MASSARD

Spain

Latest Decision Or Authorization Date
18-03-2024
Number Of Sites
1
Number Of Participants
23

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
8001: Oncology
Principal Investigator Name
Elena Garralda Cabanas
Principal Investigator Email
egarralda@vhio.net
Contact Person Name
Elena Garralda Cabanas
Contact Person Email
egarralda@vhio.net

Italy

Latest Decision Or Authorization Date
15-03-2024
Number Of Sites
2
Number Of Participants
40

Sites

Site Name
Humanitas Research Hospital
Department Name
6001: U.O. di Oncologia Medica ed Ematologia
Principal Investigator Name
Armando Santoro
Principal Investigator Email
armando.santoro@humanitas.it
Contact Person Name
Armando Santoro
Contact Person Email
armando.santoro@humanitas.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
6002: S.C. Oncologia Medica 1
Principal Investigator Name
Matteo Duca
Principal Investigator Email
matteo.duca@istitutotumori.mi.it
Contact Person Name
Matteo Duca

Germany

Latest Decision Or Authorization Date
23-02-2024
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
3001: Westdeutsches Tumorzentrum
Principal Investigator Name
Martin Metzenmacher
Principal Investigator Email
martin.metzenmacher@uk-essen.de
Contact Person Name
Martin Metzenmacher

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
IAG933

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