Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
240
Countries
8
Sites
26
Chronic myeloid leukemia
Key facts
- Sponsor
- Enliven Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 29 Jul 2022 → ongoing
- Decision date (initial)
- 2025-04-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503335-18-00
- EudraCT number
- 2022-000052-11
- ClinicalTrials.gov
- NCT05304377
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic myeloid leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10009015 | Chronic myeloid leukemia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Enliven Therapeutics Inc.
- Sponsor organisation
- Enliven Therapeutics Inc.
- Address
- 6200 Lookout Road
- City
- Boulder
- Postcode
- 80301-3319
- Country
- United States
Scientific contact point
- Organisation
- Enliven Therapeutics Inc.
- Contact name
- Clinical Development Lead
Public contact point
- Organisation
- Enliven Therapeutics Inc.
- Contact name
- Clinical Development Lead
Locations
8 EU/EEA countries · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 13 | 3 |
| France | Ongoing, recruiting | 12 | 6 |
| Germany | Ongoing, recruiting | 60 | 7 |
| Hungary | Ongoing, recruiting | 10 | 2 |
| Italy | Ongoing, recruiting | 8 | 1 |
| Netherlands | Ongoing, recruiting | 10 | 1 |
| Poland | Ongoing, recruiting | 14 | 3 |
| Spain | Ongoing, recruiting | 18 | 3 |
| Rest of world
Australia, Korea, Republic of, Israel, United States, Canada, United Kingdom
|
— | 95 | — |
Investigational sites
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven
Centre hospitalier universitaire de Liege
Hematology, Avenue De L'Hopital 1, 4000, Liege
Centre Hospitalier Universitaire De Lille
Service des Maladies du Sang, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Institut Bergonie
Service Hématologie, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Hospices Civils De Lyon
Service Hématologie, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Leon Berard
Service d’Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Et Universitaire De Limoges
Service d’Hématologie Clinique et Thérapie Cellulaire, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Universitaire Amiens Picardie
Service d’Hématologie Clinique et Thérapie Cellulaire, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Goethe University Frankfurt
Medizinische Klinik II Hämatologie/Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitat Heidelberg
III. Medizinische Klinik, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Rostock University Medical Center
Innere Medizin, Klinik III – Hämatologie, Onkologie, Palliativmedizin, Ernst-Heydemann-Strasse 6, Hansaviertel, Rostock
Charite Universitaetsmedizin Berlin KöR
Campus VirchowKlinikum Medizinische Klinik mit Schwerpunkt Hämatologie,Onkologie und Tumorimmunogie, Augustenburger Platz 1, Wedding, Berlin
Universitaet Des Saarlandes
Department of Oncology, Haematology, Rheumatology and clinical Immunology, Kirrberger Strasse 100, 66421, Homburg
Universitaetsklinikum Jena KöR
Klinik für Innere Medizin II Abteilung Hämatologie und Internistische Onkologie, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Aachen AöR
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV), Pauwelsstrasse 30, 52074, Aachen
Semmelweis University
N/A, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
University Of Pecs
N/A, Ifjusag Utja 13, 7624, Pecs
Radboud universitair medisch centrum Stichting
Department of Hematology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Instytut Hematologii I Transfuzjologii
Klinika Hematologii, Ul Indiry Gandhi 14, 02-776, Warsaw
Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu SPZOZ
Oddział hematologiczny, Ul. Mlynska 5, 33-300, Nowy Sacz
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Toruń, Ul. Stefana Batorego 18-22, 87-100, Torun
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 |
|---|---|---|---|---|---|
| Belgium | 2025-06-13 | 2025-08-13 | |||
| France | 2022-07-29 | 2024-03-12 | |||
| Germany | 2022-08-10 | 2022-08-10 | |||
| Hungary | 2025-06-19 | 2025-08-18 | |||
| Italy | 2025-06-06 | 2025-06-18 | |||
| Netherlands | 2025-06-04 | 2025-06-23 | |||
| Poland | 2025-06-05 | 2025-07-30 | |||
| Spain | 2022-08-08 | 2022-08-10 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-15 | Spain | Acceptable 2024-05-17
|
2024-05-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-15 | Spain | Acceptable 2024-09-09
|
2024-09-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-25 | Spain | Acceptable 2025-01-16
|
2025-01-16 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-02-12 | Acceptable 2025-01-16
|
2025-04-14 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-02-12 | Acceptable 2025-01-16
|
2025-04-24 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-02-12 | Acceptable 2025-01-16
|
2025-05-07 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2025-02-12 | Acceptable 2025-01-16
|
2025-04-30 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2025-02-12 | Acceptable 2025-01-16
|
2025-05-13 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-24 | Spain | Acceptable 2025-09-15
|
2025-09-15 |
| 10 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-23 | Spain | Acceptable 2026-05-11
|
2026-05-11 |