Clinical trial • Phase I • Oncology

LY3410738 for IDH1/IDH2-mutant advanced solid tumours | Cholangiocarcinoma | Chondrosarcoma | Glioma

Phase I trial of LY3410738 for IDH1/IDH2-mutant advanced solid tumours | Cholangiocarcinoma | Chondrosarcoma | Glioma. 20 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
IDH1/IDH2-mutant advanced solid tumours | Cholangiocarcinoma | Chondrosarcoma | Glioma
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
12-09-2024
First CTIS Authorization Date
29-10-2024

Trial design

Phase I trial across 3 sites in France, Spain.

Biomarker Stratified
True, biomarker: IDH1 R132; IDH2 R140; IDH2 R172
Target Sample Size
20

Recruitment

Planned Sample Size
20
Recruitment Window Months
61

Geography

Total Number Of Sites
3
Total Number Of Participants
3

France

Earliest CTIS Part Ii Submission Date
23-09-2024
Latest Decision Or Authorization Date
31-03-2025
Processing Time Days
189
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Institut Gustave Roussy
Department Name
Drug Development department and GI Oncology
Principal Investigator Name
Antoine Hollebecque
Principal Investigator Email
antoine.hollebecque@gustaveroussy.fr
Contact Person Name
Antoine Hollebecque
Site Name
Institut Bergonie
Department Name
Medical Oncology
Principal Investigator Name
Antoine Italiano
Principal Investigator Email
a.italiano@bordeaux.unicancer.fr
Contact Person Name
Antoine Italiano

Spain

Earliest CTIS Part Ii Submission Date
23-09-2024
Latest Decision Or Authorization Date
20-01-2026
Processing Time Days
484
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Jaume Capdevilla Castellon
Principal Investigator Email
jcapdevila@vhio.net
Contact Person Name
Jaume Capdevilla Castellon
Contact Person Email
jcapdevila@vhio.net

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
LY3410738

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