Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
500
Countries
4
Sites
24
Advanced solid tumors including (but not limited to), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), gastric/gastroesophageal junction adenocarcinoma (GEA), colorectal cancer (CRC), and renal cell carcinoma (RCC)
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Feb 2023 → ongoing
- Decision date (initial)
- 2024-07-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509335-60-00
- EudraCT number
- 2021-002258-98
- ClinicalTrials.gov
- NCT05029882
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors including (but not limited to), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), gastric/gastroesophageal junction adenocarcinoma (GEA), colorectal cancer (CRC), and renal cell carcinoma (RCC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10067946 | Renal cell carcinoma | 100000004864 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 21.0 | PT | 10041823 | Squamous cell carcinoma | 100000004864 |
| 20.0 | LLT | 10079440 | Non-squamous non-small cell lung cancer | 10029104 |
| 20.0 | PT | 10001150 | Adenocarcinoma gastric | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.0 | PT | 10030137 | Oesophageal adenocarcinoma | 100000004864 |
| 24.0 | LLT | 10085300 | Squamous non-small cell lung cancer | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Locations
4 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 90 | 7 |
| Germany | Ended | 12 | 3 |
| Poland | Ongoing, recruitment ended | 20 | 3 |
| Spain | Ongoing, recruitment ended | 55 | 11 |
| Rest of world
Japan, Australia, Taiwan, Israel, United States, Korea, Republic of
|
— | 323 | — |
Investigational sites
Institut Gustave Roussy
Service De Gastro-Entérologie, 39 Rue Camille Desmoulins, 94805, Villejuif Cedex
Institut Bergonie
Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Leon Berard
Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Centre Antoine Lacassagne
Oncologie, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centr Georges Francois Leclerc
Oncologie Medicale, 1 Rue Professeur Marion, 21000, Dijon
Institut De Cancerologie De L Ouest
Oncology, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Hospitalier Universitaire De Nantes
Service dOncologie medicale – Unite dOncologie thoracique, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
University Hospital Cologne AöR
Innere Medizin I, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Giessen und Marburg GmbH
Medizinische Klinik IV Organonkologie, Klinikstrasse 33, 35392, Giessen
Charite Research Organisation GmbH
Hamato Onkologische Phase-I Unit, Hamato Onkologische Phase-I Unit, Hindenburgdamm 30, Berlin
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Oddzial Onkologiczny z Pododdzialem Dziennej Chemioterapii, Ul. Monte Cassino 18, 37-700, Przemysl
Med Polonia Sp. z o.o.
Oncology, Obornicka 262, 60-693, Poznan
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oddzial Badan Wczesnych Faz, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Hospital Universitario Fundacion Alcorcon
Oncología, Calle Budapest 1, 28922, Alcorcon
Hospital Universitario De Jaen
Oncología Médica, Avenida Del Ejercito Espanol 10, 23007, Jaen
Institut Catala D'oncologia
Oncología Médica, Carretera Canyet S/n, 08916, Badalona
Hospital Clinic De Barcelona
Oncología, Calle Villarroel 170, 08036, Barcelona
Hospital General Universitario Gregorio Maranon
Neumología, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario 12 De Octubre
Oncología Médica, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Virgen De La Macarena
Oncología Médica, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Hm Sanchinarro
Oncología, Calle Ona 10, 28050, Madrid
Clinica Universidad De Navarra
Oncología Medica, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Fundacion Jimenez Diaz
Oncología, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 | 2023-02-23 | 2023-04-06 | 2025-01-29 | ||
| Poland | 2023-10-15 | 2024-02-12 | 2025-01-29 | ||
| Spain | 2023-09-25 | 2023-10-16 | 2025-01-29 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-14 | Spain | Acceptable with conditions 2024-07-11
|
2024-07-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-20 | Spain | Acceptable 2025-04-11
|
2025-04-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-01 | Spain | Acceptable 2025-08-26
|
2025-09-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-19 | Spain | Acceptable 2026-03-30
|
2026-03-31 |