Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
162
Countries
3
Sites
17
Participants with Advanced Solid Malignancies
Key facts
- Sponsor
- Kumquat Biosciences Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Oct 2024 → ongoing
- Decision date (initial)
- 2024-08-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511453-22-00
- WHO UTN
- U1111-1303-5047
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Participants with Advanced Solid Malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kumquat Biosciences Inc.
- Sponsor organisation
- Kumquat Biosciences Inc.
- Address
- 10770 Wateridge Circle
- City
- San Diego
- Postcode
- 92121-5805
- Country
- United States
Scientific contact point
- Organisation
- Kumquat Biosciences Inc.
- Contact name
- Regulatory Submissions
Public contact point
- Organisation
- Kumquat Biosciences Inc.
- Contact name
- Regulatory Submissions
Locations
3 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 42 | 5 |
| Italy | Ongoing, recruiting | 30 | 2 |
| Spain | Ongoing, recruiting | 40 | 10 |
| Rest of world
Taiwan, United States, Korea, Republic of
|
— | 50 | — |
Investigational sites
Oncopole Claudius Regaud
Oncologie Médical, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Oncologie Médical, 1 Rue Jean Burguet, 33000, Bordeaux
Centre Hospitalier Universitaire De Nantes
Oncologie thoracique, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Institut De Cancerologie De L Ouest
Oncologie Médical, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Institut Paoli Calmettes
Oncologie Médical, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O.C. Phase 1, Largo Francesco Vito 1, 00168, Rome
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Ricerca Traslazionale a Servizio dei Percorsi Oncologici, Via Mariano Semmola 52, 80131, Naples
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Quironsalud Barcelona
Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Quironsalud Malaga
Oncology, Avenida Imperio Argentina 1, 29004, Malaga
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, 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 | 2025-01-24 | 2025-03-12 | |||
| Italy | 2024-12-12 | 2025-03-26 | |||
| Spain | 2024-10-28 | 2024-11-29 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-13 | Spain | Acceptable 2024-08-29
|
2024-08-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-06 | Spain | Acceptable 2024-08-29
|
2024-09-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-19 | Spain | Acceptable | 2024-09-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-24 | Spain | Acceptable 2025-05-09
|
2025-05-09 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-25 | Spain | Acceptable 2025-08-11
|
2025-08-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-12 | Spain | Acceptable 2025-12-22
|
2025-12-23 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-09 | Acceptable 2025-12-22
|
2026-01-09 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-04-06 | Spain | Acceptable 2026-05-14
|
2026-05-18 |