Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
117
Countries
4
Sites
6
Advanced solid tumors
Key facts
- Sponsor
- Immunome Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Mar 2026 → ongoing
- Decision date (initial)
- 2026-02-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-523160-20-00
- ClinicalTrials.gov
- NCT06823167
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10003903 | B-cell lymphoma refractory | 100000004864 |
| 28.0 | PT | 10003902 | B-cell lymphoma recurrent | 100000004864 |
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 21.0 | LLT | 10048683 | Advanced cancer | 10029104 |
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
| 28.0 | PT | 10003899 | B-cell lymphoma | 100000004864 |
| 28.0 | LLT | 10003901 | B-cell lymphoma NOS | 10029104 |
| 28.0 | HLT | 10003900 | B-cell lymphomas NEC | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Immunome Inc.
- Sponsor organisation
- Immunome Inc.
- Address
- 18702 North Creek Parkway Suite 100
- City
- Bothell
- Postcode
- 98011-8019
- Country
- United States
Scientific contact point
- Organisation
- Immunome Inc.
- Contact name
- Clinical Development Operations
Public contact point
- Organisation
- Immunome Inc.
- Contact name
- Clinical Development Operations
Locations
4 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 8 | 1 |
| France | Ongoing, recruiting | 15 | 3 |
| Italy | Authorised, recruitment pending | 10 | 1 |
| Spain | Ongoing, recruiting | 8 | 1 |
| Rest of world
United States
|
— | 76 | — |
Investigational sites
Rigshospitalet
Haematology and Phase 1 Unit, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Gustave Roussy
Département d’Innovations Thérapeutiques et d’essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Institut Curie
Oncology, 26 Rue D Ulm, 75005, Paris
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Hematology, Via Pietro Albertoni 15, 40138, Bologna
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 | 2026-05-27 | 2026-05-28 | |||
| Spain | 2026-03-23 | 2026-04-27 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-21 | Denmark | Acceptable 2026-02-16
|
2026-02-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-03 | Denmark | Acceptable 2026-02-16
|
2026-03-03 |