Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
650
Countries
7
Sites
33
Breast Cancer; Advanced solid tumors including but not limited to gynecologic Cancer; Head and Neck Squamous Cell Carcinoma
Key facts
- Sponsor
- Scorpion Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Dec 2023 → ongoing
- Decision date (initial)
- 2026-01-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504807-94-00
- ClinicalTrials.gov
- NCT05768139
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Breast Cancer; Advanced solid tumors including but not limited to gynecologic Cancer; Head and Neck Squamous Cell Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10014733 | Endometrial cancer | 100000004864 |
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 21.0 | PT | 10041823 | Squamous cell carcinoma | 100000004864 |
| 21.1 | LLT | 10008229 | Cervical cancer | 10029104 |
| 20.0 | LLT | 10027475 | Metastatic breast cancer | 10029104 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Scorpion Therapeutics Inc.
- Sponsor organisation
- Scorpion Therapeutics Inc.
- Address
- 893 South Delaware Street
- City
- Indianapolis
- Postcode
- 46225-1782
- Country
- United States
Scientific contact point
- Organisation
- Scorpion Therapeutics Inc.
- Contact name
- Eli Lilly & Co.
Public contact point
- Organisation
- Scorpion Therapeutics Inc.
- Contact name
- Eli Lilly & Co.
Locations
7 EU/EEA countries · 33 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 15 | 2 |
| France | Ongoing, recruiting | 50 | 6 |
| Germany | Authorised, recruitment pending | 12 | 1 |
| Ireland | Ongoing, recruiting | 12 | 1 |
| Italy | Ongoing, recruiting | 44 | 9 |
| Netherlands | Ongoing, recruiting | 15 | 2 |
| Spain | Ongoing, recruiting | 30 | 12 |
| Rest of world
Japan, United States, Australia
|
— | 472 | — |
Investigational sites
Institut Jules Bordet
Institut Jules Bordet, Mijlenmeersstraat 90, 1070, Anderlecht
UZ Leuven
Gynaecological oncology, Herestraat 49, 3000, Leuven
Centre Antoine Lacassagne
n/a, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Institut Paoli Calmettes
n/a, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Leon Berard
n/a, 28 Rue Laennec, 69008, Lyon
Institut Bergonie
Département d’Oncologie Médicale, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Oncopole Claudius Regaud
N/A, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Gustave Roussy
N/A, 114 Rue Edouard Vaillant, 94800, Villejuif
Universitaetsklinikum Erlangen AöR
Department of Obstetrics & Gynecology, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Oncology, Via Venezia 16, 15121, Alexandria
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Oncology, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Unita Sanitaria Locale Della Romagna
Oncology, Viale Vincenzo Randi 5, 48121, Ravenna
Azienda Ospedaliero Universitaria Pisana
Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci (centro Fase I), Via Roma 67, 56126, Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Phase 1 Unit, Largo Francesco Vito 1, 00168, Rome
European Institute Of Oncology S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Centro Ricerche Cliniche Di Verona S.r.l.
Policlinico GB Rossi di Borgo Roma, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Fondazione IRCCS San Gerardo Dei Tintori
Phase 1 Research center, Via Giovanni Battista Pergolesi 33, 20900, Monza
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Salut Sant Joan De Reus
Oncology, Avinguda Del Doctor Josep Laporte 2, 43204, Reus
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Quironsalud Barcelona
oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital San Pedro
Oncology, Calle Piqueras 98, 26006, Logrono
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Hm Nou Delfos
Oncology, Avinguda De Vallcarca 151, 08023, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, 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 | 2024-03-14 | 2024-04-05 | |||
| Ireland | 2025-05-26 | 2025-05-29 | |||
| Italy | 2024-03-27 | 2024-04-05 | |||
| Netherlands | 2025-08-05 | 2026-01-14 | |||
| Spain | 2023-12-26 | 2024-01-03 |
Application history
26 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-14 | Spain | Acceptable with conditions 2023-11-20
|
2023-11-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-12 | Spain | Acceptable 2024-02-12
|
2024-02-12 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-02 | Spain | Acceptable 2024-02-12
|
2024-05-02 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-31 | Spain | Acceptable 2024-08-14
|
2024-08-19 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-16 | Spain | Acceptable 2024-12-03
|
2024-12-03 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-13 | Spain | Acceptable 2024-12-03
|
2024-12-13 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-12-18 | Spain | Acceptable 2024-12-03
|
2024-12-18 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-12-19 | Acceptable 2024-12-03
|
2024-12-19 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-01-27 | Spain | Acceptable | 2025-02-13 |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-01-27 | Acceptable | 2025-03-11 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-01-27 | Acceptable | 2025-03-25 | |
| 12 | SUBSEQUENT ADDITION OF MSC | APP-12 | 2025-01-27 | Acceptable 2024-12-03
|
2025-04-22 | |
| 13 | SUBSEQUENT ADDITION OF MSC | APP-13 | 2025-01-27 | 2025-04-25 | ||
| 14 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-05-15 | Spain | Acceptable | 2025-06-03 |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-06-19 | Spain | Acceptable | 2025-06-19 |
| 16 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-07-11 | Spain | Acceptable with conditions 2025-10-17
|
2025-10-17 |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-10-27 | Spain | Acceptable with conditions 2025-10-17
|
2025-10-27 |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-10-29 | Spain | Acceptable with conditions 2025-10-17
|
2025-10-29 |
| 19 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-11-03 | Acceptable with conditions | 2025-12-17 | |
| 20 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-11-03 | Spain | Acceptable with conditions | 2025-11-06 |
| 21 | SUBSEQUENT ADDITION OF MSC | APP-21 | 2025-11-03 | 2026-01-05 | ||
| 22 | SUBSEQUENT ADDITION OF MSC | APP-22 | 2025-11-03 | Acceptable with conditions 2025-10-17
|
2026-02-03 | |
| 23 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-11-03 | Acceptable with conditions | 2025-11-27 | |
| 24 | SUBSTANTIAL MODIFICATION | SM-14 | 2026-01-30 | Acceptable with conditions | 2026-03-25 | |
| 25 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2026-03-30 | Spain | Acceptable with conditions | 2026-03-30 |
| 26 | SUBSTANTIAL MODIFICATION | SM-15 | 2026-04-08 | Spain | Acceptable with conditions | 2026-04-17 |