Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
239
Countries
1
Sites
13
Relapsed/refractory hematological malignancies or advanced/metastatic solid tumors
Key facts
- Sponsor
- Onward Therapeutics France
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 May 2023 → ongoing
- Decision date (initial)
- 2024-06-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511936-28-00
- EudraCT number
- 2022-003576-16
- ClinicalTrials.gov
- NCT05828459
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/refractory hematological malignancies or advanced/metastatic solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
| 21.1 | LLT | 10066481 | Hematological malignancy | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Onward Therapeutics France
- Sponsor organisation
- Onward Therapeutics France
- Address
- 77 Rue De Vaugirard
- City
- Paris
- Postcode
- 75006
- Country
- France
Scientific contact point
- Organisation
- Onward Therapeutics France
- Contact name
- HERRERA Alain
Public contact point
- Organisation
- Onward Therapeutics France
- Contact name
- HERRERA Alain
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 239 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Département Hématologie Clinique et Thérapie cellulaire, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Hopital Henri Mondor - 1 rue Gustave Eiffel
Unité Hémopathies Lymphoïdes & INSERMU955, Av du Mal de Lattre de Tassigny, 94000, Créteil
CHU Caen Normandie
Institut d'Hématologie de Basse Normandie, Côte de Nacre, Hématologie, Caen
Oncopole Claudius Regaud
Medical oncology - Early Phase Unit, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Medical Oncology, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Centre Hospitalier Universitaire De Montpellier
Hematology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
Medical Oncology, 185 Rue Raymond Losserand, 75674, Paris Cedex 14
CHRU Nancy Brabois
Hematology, Allée du Morvan, 54511, Vandoeuvre les Nancy
Centre Eugène Marquis
Medical Oncology, Avenue de la Bataille de Flandres Dunkerque, 35000, Rennes
Centre Hospitalier Universitaire De Lille
Service des Maladies du Sang, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Regional De Marseille
Centre d'Essais Précoces en Cancérologie (CEPCM), 264 Rue Saint Pierre, 13005, Marseille
Institut Régional Cancer Montpellier - ICM Val d'Aurelle
Early clinical trial Unit, 208 Avenue des Apothicaires, 34298, MONTPELLIER
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
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 | 2023-05-12 | 2023-06-06 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-11 | France | Acceptable 2024-06-14
|
2024-06-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-30 | France | Acceptable 2024-10-04
|
2024-10-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-16 | France | Acceptable 2025-05-14
|
2025-06-05 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-03 | France | Acceptable 2026-01-06
|
2026-01-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-12 | France | Acceptable 2026-03-31
|
2026-04-29 |