Clinical trial • Phase I/II • Oncology

STAR0602 for Unresectable, Locally Advanced, or Metastatic Solid Tumors

Phase I/II trial of STAR0602 for Unresectable, Locally Advanced, or Metastatic Solid Tumors. 225 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Unresectable, Locally Advanced, or Metastatic Solid Tumors
Trial Stage
Phase I/II

Key dates

Initial CTIS Submission Date
19-04-2024
First CTIS Authorization Date
08-07-2024

Trial design

Phase I/II trial across 12 sites in Spain, France.

Target Sample Size
225

Recruitment

Planned Sample Size
225
Recruitment Window Months
23

Geography

Total Number Of Sites
12
Total Number Of Participants
73

Spain

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
15-04-2025
Processing Time Days
291
Number Of Sites
7
Number Of Participants
23

Sites

Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Eduardo Castañon
Contact Person Email
ecastanon@unav.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Susana Roselló
Contact Person Email
srosello@incliva.es
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
NEXT Madrid Phase I trials
Contact Person Name
Valentina Boni
Contact Person Email
vboni@nextoncology.eu
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Elena Garralda
Contact Person Email
egarralda@vhio.net
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Ignacio Matos
Contact Person Email
imatos@unav.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
START Madrid
Contact Person Name
Manuel Pedregal
Site Name
Hospital Quironsalud Barcelona
Department Name
Medical Oncology
Contact Person Name
Omar Saavedra
Contact Person Email
osaavedra@nextoncology.eu

France

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
04-09-2025
Processing Time Days
475
Number Of Sites
5
Number Of Participants
50

Sites

Site Name
Institut Bergonié
Department Name
Oncologie Médical
Contact Person Name
Antoine Italiano
Site Name
Institut Gustave Roussy
Department Name
DITEP
Contact Person Name
Aurélien Marabelle
Site Name
Centre Leon Berard
Department Name
Oncologie Médicale
Contact Person Name
Philippe Cassier
Site Name
Oncopole Claudius Regaud
Department Name
Oncologie Médicale
Contact Person Name
Carlos Gomez Roca
Site Name
Institut Curie
Department Name
Oncologie Médicale
Contact Person Name
Clara Vacheret
Contact Person Email
clara.vacheret@curie.fr

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
STAR0602
First In Human
Yes

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