Phase 1 open label trial of MST-0312 alone and in combination in subjects with solid malignancies

2025-524446-10-00 Protocol MST-0312-1001 Human pharmacology (Phase I) - First administration to humans Ongoing, recruiting

Start 1 Apr 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 7 sites · Protocol MST-0312-1001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans
Status Ongoing, recruiting
Participants planned 42
Countries 1
Sites 7

Solid Malignancies

Key facts

Sponsor
Mestag Therapeutics Limited
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
1 Apr 2026 → ongoing
Decision date (initial)
2026-03-13
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Solid Malignancies

VersionLevelCodeTermSystem organ class
21.1 LLT 10065252 Solid tumor 10029104

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Mestag Therapeutics Limited

Sponsor organisation
Mestag Therapeutics Limited
Address
Suite 15, Science Village, Chesterford Park, Little Chesterford Science Village Chesterford Park
City
Saffron Walden
Postcode
CB10 1XL
Country
United Kingdom

Scientific contact point

Organisation
Mestag Therapeutics Limited
Contact name
Colin Lunt

Public contact point

Organisation
Mestag Therapeutics Limited
Contact name
Colin Lunt

Locations

1 EU/EEA country · 7 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ongoing, recruiting 42 7
Rest of world 0

Investigational sites

Spain

7 sites · Ongoing, recruiting
Hospital Universitario Fundacion Jimenez Diaz
Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Quironsalud Barcelona
Instituto de Oncología de Barcelona, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Clinico Universitario De Valencia
Oncología Médica, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Oncología Médica, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Hm Sanchinarro
Centro Integral Oncológico Clara Campall (CIOCC) Phase I trials unit, Calle Ona 10, 28050, Madrid
Clinica Universidad De Navarra
Inmunología médica & inmunoterapía, Pio XII Etorbidea 36, 31008, Pamplona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2026-04-01 2026-04-09

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-02-02 Spain Acceptable
2026-03-11
2026-03-13