Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
198
Countries
3
Sites
22
Phase 1a Monotherapy Dose Escalation and Exploration: HER2 mutant, HER2 amplified or HER2 positive solid tumor Phase 1a Dose Escalation Combination with T-DXd: HER2 mutant Non-small Cell Lung Cancer Phase 1a Dose Escalation Combination with T-DM1: HER2 positive Metastatic Breast Cancer Phase 1b Monotherapy Dose Expansion: HER2 mutant Non-small Cell Lung Cancer
Key facts
- Sponsor
- Enliven Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Sep 2023 → ongoing
- Decision date (initial)
- 2023-06-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502695-23-00
- ClinicalTrials.gov
- NCT05650879
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Phase 1a Monotherapy Dose Escalation and Exploration: HER2 mutant, HER2 amplified or HER2 positive solid tumor Phase 1a Dose Escalation Combination with T-DXd: HER2 mutant Non-small Cell Lung Cancer Phase 1a Dose Escalation Combination with T-DM1: HER2 positive Metastatic Breast Cancer Phase 1b Monotherapy Dose Expansion: HER2 mutant Non-small Cell Lung Cancer
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
- Chief Medical Officer
Public contact point
- Organisation
- Enliven Therapeutics Inc.
- Contact name
- Chief Medical Officer
Locations
3 EU/EEA countries · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 40 | 7 |
| Italy | Ended | 40 | 6 |
| Spain | Ongoing, recruitment ended | 40 | 9 |
| Rest of world
Australia, Taiwan, United States, Korea, Republic of
|
— | 78 | — |
Investigational sites
Centr Georges Francois Leclerc
Medical Oncology, 1 Rue Professeur Marion, 21000, Dijon
Assistance Publique Hopitaux De Marseille
Hôpital de la Timone CEPCM_Centre d’essais précoces en cancérologie de Marseille, 264 Rue Saint Pierre, 13005, Marseille
Centre Francois Baclesse
Medical Oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Hospitalier Universitaire De Rennes
Pneumology, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonie
Medical Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Centro Di Riferimento Oncologico Di Aviano
Dipartimento Oncologia Medica, Via Franco Gallini 2, 33081, Aviano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Fase 1, Largo Francesco Vito 1, 00168, Rome
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Oncologia Medica Degenza, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Humanitas Research Hospital
Unità di Fase 1, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Socio Sanitaria Territoriale Di Monza
Centro di Ricerca di Fase I, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona
SOD Clinica Oncologica, Via Conca 71, 60126, Ancona
Hospital Universitario Y Politecnico La Fe
n/a, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Medical Oncology Department, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Medical Oncology, Av Alcalde Rovira Roure 80, 25198, Lleida
Catalan Institute Of Oncology
n/a, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Virgen De La Macarena
n/a, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Hm Nou Delfos
Medical Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Fundacion Instituto Valenciano De Oncologia
Servicio de Oncología, Calle Professor Beltran Baguena 8, 46009, Valencia
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 | 2023-10-02 | 2025-06-30 | 2023-10-17 | 2025-05-15 | |
| Italy | 2023-09-27 | 2025-10-14 | 2023-12-05 | 2025-05-15 | |
| Spain | 2023-10-06 | 2023-11-10 | 2025-05-15 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-14 | Spain | Acceptable with conditions 2023-05-29
|
2023-05-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-06-27 | Acceptable with conditions 2023-05-29
|
2023-06-27 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-06-27 | Spain | Acceptable with conditions 2023-05-29
|
2023-06-27 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-07-03 | Spain | Acceptable with conditions 2023-05-29
|
2023-07-03 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-07-05 | Spain | Acceptable 2023-09-12
|
2023-09-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-10-16 | Spain | Acceptable with conditions 2024-01-22
|
2024-01-25 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-02-09 | Spain | Acceptable 2024-04-29
|
2024-04-29 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-07-05 | Spain | Acceptable 2024-08-28
|
2024-08-28 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-10-01 | Spain | Acceptable | 2024-10-07 |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-03-17 | Spain | Acceptable 2025-06-04
|
2025-06-04 |