Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
170
Countries
2
Sites
26
Relapsed or refractory solid tumors or non-Hodgkin lymphoma
Key facts
- Sponsor
- Kronos Bio Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 20 Dec 2023 → 13 Nov 2024
- Decision date (initial)
- 2023-11-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503739-16-00
- ClinicalTrials.gov
- NCT04718675
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed or refractory solid tumors or non-Hodgkin lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kronos Bio Inc.
- Sponsor organisation
- Kronos Bio Inc.
- Address
- 1300 South El Camino Real Suite 300
- City
- San Mateo
- Postcode
- 94402-2971
- Country
- United States
Scientific contact point
- Organisation
- Kronos Bio Inc.
- Contact name
- Marc Besman
Public contact point
- Organisation
- Kronos Bio Inc.
- Contact name
- Marc Besman
Locations
2 EU/EEA countries · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 20 | 12 |
| Spain | Ended | 30 | 14 |
| Rest of world
United Kingdom, United States
|
— | 120 | — |
Investigational sites
Centre Francois Baclesse
Urology & Clinic Research, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Assistance Publique Hopitaux De Marseille
Centre d’Essais en Cancérologie de Marseille, 264 Rue Saint Pierre, 13005, Marseille
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Centre Oscar Lambret
General Oncology, 3 Rue Frederic Combemale, 59000, Lille
Institut Paoli-Calmettes
Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Poitiers
Medical Oncology, 2 Rue De La Miletrie, 86000, Poitiers
Institut Bergonie
Medical Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Centre Hospitalier Lyon Sud
Medical Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Institut De Cancerologie De L Ouest
Oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
Institut Curie
Clinical Investigation Unit, 26 Rue D Ulm, 75005, Paris
Centre Leon Berard
Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Unviersitario Miguel Servet
Oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
Oncology, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
University Clinical Hospital Virgen De La Arrixaca
Oncology, Carretera De Cartagena Sn, El Palmar, Murcia
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, 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 |
|---|---|---|---|---|---|
| Spain | 2023-12-20 | 2023-12-28 | 2024-11-13 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-26 | Spain | Acceptable 2023-11-13
|
2023-11-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-18 | Acceptable | 2024-02-15 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-21 | Spain | Acceptable | 2024-01-11 |