Clinical trial • Phase I • Oncology

Clinical trial in Advanced solid tumors with MET genetic alterations

Phase I trial for Advanced solid tumors with MET genetic alterations. 68 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced solid tumors with MET genetic alterations
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
26-04-2024
First CTIS Authorization Date
05-07-2024

Trial design

Phase I trial across 4 sites in France.

Biomarker Stratified
True, biomarker: MET genetic alterations
Target Sample Size
68

Eligibility

Recruits 68 Vulnerable population not selected (isVulnerablePopulationSelected: false). No consent or assent details provided..

Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected: false). No consent or assent details provided.

Recruitment

Planned Sample Size
68
Recruitment Window Months
90

Geography

Total Number Of Sites
4
Total Number Of Participants
68

France

Earliest CTIS Part Ii Submission Date
12-03-2024
Latest Decision Or Authorization Date
21-10-2025
Processing Time Days
588
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Pneumology and Physiology Unit
Principal Investigator Name
Denis Moro-Sibilot
Principal Investigator Email
dmoro-sibilot@chu-grenoble.fr
Contact Person Name
Denis Moro-Sibilot
Contact Person Email
dmoro-sibilot@chu-grenoble.fr
Site Name
Unite De Recherche Clinique HIA Begin
Department Name
Clinical Research Unit
Principal Investigator Name
Carole Helissey
Principal Investigator Email
carole.helissey@gmail.com
Contact Person Name
Carole Helissey
Contact Person Email
carole.helissey@gmail.com
Site Name
Institut Gustave Roussy
Department Name
Médecine Oncologique
Principal Investigator Name
Benjamin Besse
Principal Investigator Email
benjamin.besse@gustaveroussy.fr
Contact Person Name
Benjamin Besse
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Principal Investigator Name
Philippe Cassier
Principal Investigator Email
philippe.cassier@lyon.unicancer.fr
Contact Person Name
Philippe Cassier

Sponsor

Primary sponsor

Full Name
Turning Point Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Bristol Myers Squibb International Corporation
Responsibilities
GSM-CT public/scientific contact (functional contact listed in sponsor public and scientific contacts)

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