Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
95
Countries
1
Sites
21
Solid Tumors
Key facts
- Sponsor
- Immatics Biotechnologies GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 May 2022 → ongoing
- Decision date (initial)
- 2023-09-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506854-19-00
- EudraCT number
- 2021-004326-30
- ClinicalTrials.gov
- NCT05359445
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Immatics Biotechnologies GmbH
- Sponsor organisation
- Immatics Biotechnologies GmbH
- Address
- Paul-Ehrlich-Strasse 15, Waldhaeuser Waldhaeuser
- City
- Tuebingen
- Postcode
- 72076
- Country
- Germany
Scientific contact point
- Organisation
- Immatics Biotechnologies GmbH
- Contact name
- Clinical Development
Public contact point
- Organisation
- Immatics Biotechnologies GmbH
- Contact name
- Clinical Development
Locations
1 EU/EEA country · 21 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 95 | 21 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Wuerzburg AöR
Interdisziplinäres Studienzentrum mit ECTU, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Charite Universitaetsmedizin Berlin KöR
Klinik für Hämatologie und Onkologie, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
NCT/UCC Early Clinical Trial Unit, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Marien Hospital Duesseldorf GmbH
Klinik für Onkologie / Hämatologie und Palliativmedizin, Rochusstrasse 2, Pempelfort, Duesseldorf
Goethe University Frankfurt
Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Medical Center - University Of Freiburg
Klinik für Innere Medizin I, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
III. Medizinische Klinik, Langenbeckstrasse 1, Oberstadt, Mainz
Klinikum rechts der Isar der TU Muenchen AöR
Klinik und Poliklinik für Innere Medizin III, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Bonn AöR
Medizinische Klinik III, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Regensburg AöR
Klinik für Innere Medizin 3, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Tuebingen AöR
Comprehensive Cancer Center Tübingen, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Universitaetsklinikum Muenster AöR
Medizinische Klinik A, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Thoraxklinik Heidelberg gGmbH
Studienzentrum Thoraxonkologie, Roentgenstrasse 1, Rohrbach, Heidelberg
Universitaet Leipzig
Universitäres Krebszentrum Leipzig (UCCL), Liebigstrasse 22, Zentrum-Suedost, Leipzig
Klinikum Nuernberg
Klinik für Innere Medizin 5, Abteilung Onkologie/Hämatologie, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
Universitaetsklinikum Erlangen AöR
Interdisciplinary Clinical Trial Unit with ECTU, Ulmenweg 18, Innenstadt, Erlangen
Universitaetsklinikum Ulm AöR
ECTU-Early Clinical Trials Unit Universitätsklinikum Ulm Comprehensive Cancer Center Ulm_CCCU, Albert-Einstein-Allee 23, Eselsberg, Ulm
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin III, Flemmingstrasse 2, Altendorf, Chemnitz
Universitaetsklinikum Heidelberg AöR
Nationales Zentrum für Tumorkrankheiten, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Medizinische Hochschule Hannover
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Schleswig-Holstein
Campus Kiel, Medizinische Klinik II Hämatologie und Onkologie, Karl-Lennert Tumorzentrum, Arnold-Heller-Strasse 3, Brunswik, Kiel
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 |
|---|---|---|---|---|---|
| Germany | 2022-05-19 | 2022-05-19 | 2026-01-05 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-01 | Germany | Acceptable 2023-09-22
|
2023-09-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-07 | Germany | Acceptable 2024-01-19
|
2024-02-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-28 | Germany | Acceptable 2024-04-12
|
2024-04-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-04 | Germany | Acceptable with conditions 2024-12-03
|
2024-12-04 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-22 | Germany | Acceptable 2025-06-25
|
2025-06-30 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-14 | Germany | Acceptable | 2025-08-19 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-20 | Germany | Acceptable | 2026-03-10 |