Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
26
Countries
2
Sites
2
Small Cell Lung Cancer
Key facts
- Sponsor
- Evergreen Theragnostics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 May 2025 → ongoing
- Decision date (initial)
- 2025-02-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Small Cell Lung Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041067 | Small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Evergreen Theragnostics Inc.
- Sponsor organisation
- Evergreen Theragnostics Inc.
- Address
- 27 Commerce Street
- City
- Springfield
- Postcode
- 07081-3014
- Country
- United States
Scientific contact point
- Organisation
- Evergreen Theragnostics Inc.
- Contact name
- Dalma Seboek
Public contact point
- Organisation
- Evergreen Theragnostics Inc.
- Contact name
- Dalma Seboek
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Temporarily halted | 10 | 1 |
| Italy | Authorised, recruitment pending | 10 | 1 |
| Rest of world
United States
|
— | 6 | — |
Investigational sites
Medizinische Universitaet Innsbruck
University Hospital for Nuclear Medicine, Anichstrasse 35, 6020, Innsbruck
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 |
|---|---|---|---|---|---|
| Austria | 2025-05-27 | 2025-12-16 | 2026-01-30 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-117356
- Halt date
- 2026-01-30
- Member states concerned
- Austria
- Publication date
- 2026-02-02
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The temporary halt was implemented to allow amendment of the protocol following evaluation of dosimetry data from the first treated subject. The amendment is intended to modify the dose-escalation scheme and patient selection criteria, including use of a companion diagnostic approach, in order to deliver sufficient tumor radiation while minimizing exposure to critical and off-target organs and thereby improve the benefit–risk balance.
- Follow-up measures
- No further dosing or recruitment will occur during the temporary halt. Any protocol changes impacting subjects will be implemented only after approval of the planned substantial protocol amendment.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-07 | Austria | Acceptable with conditions 2025-02-03
|
2025-02-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-11 | Austria | Acceptable 2025-04-07
|
2025-04-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-25 | Austria | Acceptable 2025-04-07
|
2025-11-25 |