Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
42
Countries
1
Sites
1
Advanced Solid Cancers
Key facts
- Sponsor
- Neogene Therapeutics B.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Apr 2022 → 11 Jun 2025
- Decision date (initial)
- 2024-12-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518201-18-00
- EudraCT number
- 2021-006406-73
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Cancers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Neogene Therapeutics B.V.
- Sponsor organisation
- Neogene Therapeutics B.V.
- Address
- Matrix VII, Science Park 106 Science Park 106
- City
- Amsterdam
- Postcode
- 1098 XG
- Country
- Netherlands
Scientific contact point
- Organisation
- Neogene Therapeutics B.V.
- Contact name
- AstraZeneca Study Information Center
Public contact point
- Organisation
- Neogene Therapeutics B.V.
- Contact name
- AstraZeneca Study Information Center
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 42 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
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 |
|---|---|---|---|---|---|
| Netherlands | 2022-04-28 | 2022-05-16 | 2022-11-11 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-61476
- Halt date
- 2022-11-11
- Member states concerned
- Netherlands
- Publication date
- 2024-12-05
- Reason
- Sponsor decision
- Explanation
- This temporary halt was first notified to the CCMO under the CTD 24Nov2022, the details submitted at the time were:
The Netherlands Cancer Institute (NKI), the single site conducting the above referenced study, was instructed to pause recruitment by the Sponsor on Friday 11 November 2022. The voluntary decision to pause recruitment and pre-screening was taken based on an interim assessment of the study which observed a low success rate of TCR identification for the subjects that have been pre-screened to date. Neogene believes the observed low success rate is related to the intrinsic variability of tumour biospecimens collected from the subjects pre-screened which has impacted the downstream steps of biospecimen processing and, subsequently, resulted in inadequate TCR identification. These findings do not constitute a safety concern for the subjects whose biospecimens were successfully processed and progressed to TCR selection.
No subjects have yet received treatment with NT-125. For the subjects already recruited that have undergone tumour biospecimen collection and who are currently undergoing TCR identification, the Sponsor intends for these subjects to remain in the study, continue the process, and receive the investigational treatment if TCRs are successfully identified as per the approved protocol and procedures.
Neogene continues to investigate the issues and plans to further refine the TCR identification and selection process with the intent to enhance the success rate; all corrective actions and future process changes will be promptly communicated to CCMO and VWS, prior to resuming recruitment and pre-screening. - Follow-up measures
- Currently there is one participant in follow up. No more participants are planned to be dosed or recruited whilst the temporary halt is in force.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-15 | Netherlands | Acceptable 2024-12-02
|
2024-12-02 |