Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
471
Countries
3
Sites
14
Oncology
Key facts
- Sponsor
- Systimmune Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 27 May 2025 → ongoing
- Decision date (initial)
- 2024-05-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506539-14-00
- ClinicalTrials.gov
- NCT05983432
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Oncology
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
| 21.1 | PT | 10029520 | Non-small cell lung cancer stage IIIA | 100000004864 |
| 21.1 | PT | 10029516 | Non-small cell lung cancer stage 0 | 100000004864 |
| 21.1 | PT | 10029517 | Non-small cell lung cancer stage I | 100000004864 |
| 21.1 | PT | 10029521 | Non-small cell lung cancer stage IIIB | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 21.1 | PT | 10029518 | Non-small cell lung cancer stage II | 100000004864 |
| 21.1 | PT | 10029519 | Non-small cell lung cancer stage III | 100000004864 |
| 21.1 | PT | 10029515 | Non-small cell lung cancer recurrent | 100000004864 |
| 21.1 | PT | 10029522 | Non-small cell lung cancer stage IV | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Systimmune Inc.
- Sponsor organisation
- Systimmune Inc.
- Address
- 15318 Northeast 95th Street
- City
- Redmond
- Postcode
- 98052-2517
- Country
- United States
Scientific contact point
- Organisation
- Systimmune Inc.
- Contact name
- Jimmy Zhao
Public contact point
- Organisation
- Systimmune Inc.
- Contact name
- Jimmy Zhao
Locations
3 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 21 | 4 |
| Italy | Ongoing, recruiting | 39 | 2 |
| Spain | Ongoing, recruiting | 35 | 8 |
| Rest of world
United States, Japan
|
— | 376 | — |
Investigational sites
Institut De Cancerologie De L Ouest
Medical Oncology, Bd Du Professeur Jacques Monod, 44800, St Herblain
Institut Gustave Roussy
DITEP, 114 Rue Edouard Vaillant, 94800, Villejuif
Assistance Publique Hopitaux De Paris
Medical Oncology, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Centre Leon Berard
Medical Oncology, 28 Rue Laennec, 69008, Lyon
Humanitas Research Hospital
Medical Oncology Unit, Humanitas Cancer Center, IRCCS Istituto Clinico Humanitas, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Department of Oncology, Istituto di Candiolo Fondazione del Piemonte per l’oncologia IRCCS, Strada Provinciale 142 Km 3,95, 10060, Candiolo
Hospital Universitario 12 De Octubre
Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Beata Maria Ana
Oncology, Calle Del Doctor Esquerdo No. 83, 28007, Madrid
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Fundacion Rioja Salud
Oncology, Calle Piqueras 98, 26006, Logrono
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 | 2025-06-09 | 2025-06-24 | |||
| Italy | 2025-05-27 | 2025-06-13 | |||
| Spain | 2024-07-16 | 2024-07-22 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-68302
- Halt date
- 2025-01-17
- Member states concerned
- Spain
- Publication date
- 2025-01-28
- Reason
- Sponsor decision
- Explanation
- There is a substantial modification under review by EU CTR that will allow for global alignment of protocol and clarification of dose expansion cohorts. Recruitment in EU will re-start under this updated globally harmonized protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-26 | Spain | Acceptable with conditions 2024-05-20
|
2024-05-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-31 | Acceptable with conditions | 2024-07-05 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-04 | Spain | Acceptable with conditions | 2024-06-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-13 | Acceptable with conditions | 2024-07-24 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-01-10 | Spain | Acceptable with conditions 2025-04-15
|
2025-04-15 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-12 | Spain | Acceptable with conditions 2025-12-11
|
2025-12-11 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-06 | Acceptable with conditions | 2026-04-01 |