Clinical trial • Phase I • Oncology

MOMA-313 for Advanced or metastatic solid tumours

Phase I trial of MOMA-313 for Advanced or metastatic solid tumours. 125 participants.

Overview

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

Key dates

Initial CTIS Submission Date
30-10-2024
First CTIS Authorization Date
18-02-2025

Trial design

Phase I trial across 3 sites in Spain.

Target Sample Size
125

Eligibility

Recruits 125 Vulnerable population selected (isVulnerablePopulationSelected=true). No details provided on consent or assent procedures or age-specific consent documents..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected=true). No details provided on consent or assent procedures or age-specific consent documents.

Recruitment

Planned Sample Size
125
Recruitment Window Months
20

Geography

Total Number Of Sites
3
Total Number Of Participants
125

Spain

Earliest CTIS Part Ii Submission Date
23-01-2025
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
365
Number Of Sites
3
Number Of Participants
48

Sites

Site Name
Institut Catala D'oncologia
Department Name
Servicio de oncologia
Principal Investigator Name
Marta Gil Martin
Principal Investigator Email
mgilmartin@iconcologia.net
Contact Person Name
Marta Gil Martin
Contact Person Email
mgilmartin@iconcologia.net
Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de oncologia
Principal Investigator Name
Joaquin Mateo Valderrama
Principal Investigator Email
jmateo@vhio.net
Contact Person Name
Joaquin Mateo Valderrama
Contact Person Email
jmateo@vhio.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Servicio de oncologia
Principal Investigator Name
Victor Moreno Garcia
Principal Investigator Email
victor.moreno@startmadrid.com
Contact Person Name
Victor Moreno Garcia
Contact Person Email
victor.moreno@startmadrid.com

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
MOMA-313
Routes Of Administration
Oral
Route
Oral

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