Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ended
Participants planned
300
Countries
2
Sites
16
Non-Small Cell Lung Cancer
Key facts
- Sponsor
- Mythic Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Apr 2024 → 1 Nov 2025
- Decision date (initial)
- 2024-02-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504630-22-00
- ClinicalTrials.gov
- NCT05652868
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Mythic Therapeutics Inc.
- Sponsor organisation
- Mythic Therapeutics Inc.
- Address
- 100 Beaver Street
- City
- Waltham
- Postcode
- 02453-8400
- Country
- United States
Scientific contact point
- Organisation
- Mythic Therapeutics Inc.
- Contact name
- Helen Chalk
Public contact point
- Organisation
- Mythic Therapeutics Inc.
- Contact name
- Helen Chalk
Locations
2 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 30 | 7 |
| Spain | Ended | 30 | 9 |
| Rest of world
Taiwan, Korea, Republic of, Australia, United Kingdom, United States
|
— | 240 | — |
Investigational sites
Institut Universitaire Du Cancer Toulouse-Oncopole
Medical Oncology, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut De Cancerologie De L Ouest
Medical Oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
Institut Curie
Pneumology, 26 Rue D Ulm, 75005, Paris
Assistance Publique Hopitaux De Marseille
Centre d'essais précoces en Cancérologie de Marseille, 264 Rue Saint Pierre, 13005, Marseille
Institut Gustave Roussy
Medical Oncology, 39 Rue Camille Desmoulins, 94805, Villejuif Cedex
Institut Bergonie
Medical Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Hospital Hm Nou Delfos
Medical Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinico Universitario Lozano Blesa
Medical Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Instituto Oncologico Dr. Rosell S.L.
Medical Oncology, Calle De Sabino Arana Num. 5, 08028, Barcelona
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Medical Oncology, Avenida Menendez Y Pelayo 4, 46010, Valencia
Hospital Quironsalud Malaga
Medical Oncology, Avenida Imperio Argentina 1, 29004, Malaga
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-07-18 | 2024-08-12 | 2025-11-01 | ||
| Spain | 2024-04-19 | 2024-05-20 | 2025-11-01 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-17 | Spain | Acceptable with conditions 2024-02-19
|
2024-02-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-17 | Spain | Acceptable 2024-07-22
|
2024-07-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-23 | Spain | Acceptable 2024-12-02
|
2024-12-02 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-21 | Spain | Acceptable 2024-12-02
|
2025-01-21 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-26 | Spain | Acceptable 2025-05-14
|
2025-05-14 |