Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
129
Countries
6
Sites
18
Advanced Hematologic 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
- 30 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511457-22-00
- WHO UTN
- U1111-1309-0750
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Hematologic Malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10066481 | Hematological malignancy | 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
6 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 12 | 3 |
| Germany | Ended | 12 | 2 |
| Italy | Ongoing, recruitment ended | 15 | 4 |
| Netherlands | Ended | 9 | 1 |
| Poland | Ongoing, recruitment ended | 12 | 4 |
| Spain | Ongoing, recruitment ended | 9 | 4 |
| Rest of world
United Kingdom, Australia, United States
|
— | 60 | — |
Investigational sites
CHU de Tours - Hopital Bretonneau
Hematology, 2 boulevard Tonnellé, 37044, Tours Cedex 01
Centre Leon Berard
Medical oncology, 28 Rue Laennec, 69008, Lyon
Hôpital de la Timone
Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM), 264 Boulevard de Saint Pierre, 13005, Marseille
Universitaetsklinikum Jena KöR
Hematology and internal Oncology, Am Klinikum 1, Lobeda, Jena
Medizinische Hochschule Hannover
Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
DIAGNOSTICA PER IMMAGINI, RADIOTERAPIA ONCOLOGICA ED EMATOLOGIA, Largo Francesco Vito 1, 00168, Rome
ASST Grande Ospedale Metropolitano Niguarda
Ematologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Ematologia, Via Francesco Sforza 28, 20122, Milan
Radboud universitair medisch centrum Stichting
Department of Hematology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Copernicus Podmiot Leczniczy Sp. z o.o.
Wojewódzkie Centrum Onkologii, Al. Zwyciestwa 31/32, 80-219, Gdansk
Aidport Sp. z o.o.
AIDPORT SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario 12 De Octubre
Hematology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Regional De Malaga
Hematology and Hemotherapy, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario La Paz
Hematology and Hemotherapy, Paseo De La Castellana 261, 28046, 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 | 2025-03-19 | ||||
| Germany | 2025-04-29 | ||||
| Italy | 2025-02-20 | 2025-03-10 | 2026-03-03 | ||
| Netherlands | 2025-07-31 | ||||
| Poland | 2025-01-30 | 2025-09-30 | 2026-03-03 | ||
| Spain | 2025-02-07 | 2025-07-17 | 2026-03-03 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-05 | Spain | Acceptable 2025-01-15
|
2025-01-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-24 | Acceptable 2025-01-15
|
2025-01-24 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-05 | Acceptable | 2025-03-17 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-02-11 | 2025-04-29 | ||
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-13 | Acceptable | 2025-04-30 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-23 | Spain | Acceptable 2025-08-20
|
2025-08-20 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-19 | Spain | Acceptable 2026-01-19
|
2026-01-19 |