Clinical trial • Phase I • Oncology

Clinical trial in Advanced or metastatic solid tumors

Phase I trial for Advanced or metastatic solid tumors. 132 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced or metastatic solid tumors
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
11-11-2025
First CTIS Authorization Date
17-03-2026

Trial design

Phase I trial across 7 sites in France, Ireland, Spain.

Target Sample Size
132

Recruitment

Planned Sample Size
132
Recruitment Window Months
30

Geography

Total Number Of Sites
7
Total Number Of Participants
48

France

Earliest CTIS Part Ii Submission Date
11-03-2026
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
7
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
Institut Gustave Roussy
Department Name
Innovation thérapeutique et essais cliniques précoces
Principal Investigator Name
Joana MOURATO RIBEIRO
Principal Investigator Email
joana-mourato.ribeiro@gustaveroussy.fr
Contact Person Name
Joana MOURATO RIBEIRO
Site Name
Fondation Hopital Saint Joseph
Department Name
Oncologie
Principal Investigator Name
Marine SLIM
Principal Investigator Email
mslim@ghpsj.fr
Contact Person Name
Marine SLIM
Contact Person Email
mslim@ghpsj.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie Médicale
Principal Investigator Name
Mario CAMPONE
Principal Investigator Email
mario.campone@ico.unicancer.fr
Contact Person Name
Mario CAMPONE
Contact Person Email
mario.campone@ico.unicancer.fr

Ireland

Earliest CTIS Part Ii Submission Date
24-02-2026
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
24
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Mater Misericordiae University Hospital
Department Name
Oncology
Principal Investigator Name
Austin Duffy
Principal Investigator Email
austin.duffy@startdublin.com
Contact Person Name
Austin Duffy
Contact Person Email
austin.duffy@startdublin.com

Spain

Earliest CTIS Part Ii Submission Date
02-03-2026
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
15
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology
Principal Investigator Name
Juan José Soto Castillo
Principal Investigator Email
juanj.soto@startmadrid.com
Contact Person Name
Juan José Soto Castillo
Contact Person Email
juanj.soto@startmadrid.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Principal Investigator Name
Bernard Doger de Speville
Principal Investigator Email
bernard.doger@startmadrid.com
Contact Person Name
Bernard Doger de Speville
Contact Person Email
bernard.doger@startmadrid.com
Site Name
Hospital Hm Nou Delfos
Department Name
Oncology
Principal Investigator Name
Tatiana Hernandez Guerrero
Principal Investigator Email
Tatiana.hernandez@start-barcelona.com
Contact Person Name
Tatiana Hernandez Guerrero

Sponsor

Primary sponsor

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

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