Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
3
Countries
1
Sites
1
Somatostatin Receptor Positive Neuroendocrine Tumours (NETs)
To assess the incidence of second primary haematological and non-haematological malignancies
Key facts
- Sponsor
- Ariceum Therapeutics GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 6 Jan 2022 → 29 Apr 2025
- Decision date (initial)
- 2024-10-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Ariceum Therapeutics GmbH
External identifiers
- EU CT number
- 2024-515071-35-00
- EudraCT number
- 2020-003640-88
- ClinicalTrials.gov
- NCT05017662
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
To assess the incidence of second primary haematological and non-haematological malignancies
Secondary objectives 2
- To evaluate the long-term safety profile of 177Lu-IPN01072
- To evaluate the overall survival
Conditions and MedDRA coding
Somatostatin Receptor Positive Neuroendocrine Tumours (NETs)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10052399 | Neuroendocrine tumour | 100000004864 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2015-002867-41 | An international multi-center, open-label study to evaluate safety, tolerability, biodistribution, dosimetry and preliminary efficacy of 177Lu-OPS201 for the therapy of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP NETs)., Eine internationale multizentrische, offene Studie zur Bewertung der Sicherheit, Verträglichkeit, Biodistribution, Dosimetrie und der vorläufigen Wirksamkeit von 177Lu-OPS201 für die Therapie Somatostatin-Rezeptor-positiver gastroenteropankreatischer neuroendokriner Tumore (GEP NETs)., Eine internationale multizentrische, offene Studie zur Bewertung der Sicherheit, Verträglichkeit, Biodistribution, Dosimetrie und der vorläufigen Wirksamkeit von 177Lu-OPS201 für die Therapie Somatostatin-Rezeptor-positiver neuroendokriner Tumore (NETs). (Sub-Studie des Master-Protokolls Ipsen 001 Version 1.0: 02 Februar 2018) , Eine internationale multizentrische, offene Studie zur Bewertung der Sicherheit, Verträglichkeit, Biodistribution, Dosimetrie und der vorläufigen Wirksamkeit von 177Lu-OPS201 für die Therapie Somatostatin-Rezeptor-positiver neuroendokriner Tumore (NETs). , Eine internationale multizentrische, offene Studie zur Bewertung der Sicherheit, Verträglichkeit, Biodistribution, Dosimetrie und der vorläufigen Wirksamkeit von 177Lu-OPS201 für die Therapie Somatostatin-Rezeptor-positiver neuroendokriner Tumore (NETs). (Sub-Studie des Master-Protokolls Ipsen 001 Version 1.0: 02 Februar 2018) , Eine internationale multizentrische, offene Studie zur Bewertung der Sicherheit, Verträglichkeit, Biodistribution, Dosimetrie und der vorläufigen Wirksamkeit von 177Lu-OPS201 für die Therapie Somatostatin-Rezeptor-positiver neuroendokriner Tumore (NETs). (Sub-Studie des Master-Protokolls Ipsen 001 Version 1.0: 02 Februar 2018) , Eine internationale multizentrische, offene Studie zur Bewertung der Sicherheit, Verträglichkeit, Biodistribution, Dosimetrie und der vorläufigen Wirksamkeit von 177Lu-OPS201 für die Therapie Somatostatin-Rezeptor-positiver neuroendokriner Tumore (NETs). (Sub-Studie des Master-Protokolls Ipsen 001 Version 1.0: 02 Februar 2018) , Eine internationale multizentrische, offene Studie zur Bewertung der Sicherheit, Verträglichkeit, Biodistribution, Dosimetrie und der vorläufigen Wirksamkeit von 177Lu-OPS201 für die Therapie Somatostatin-Rezeptor-positiver neuroendokriner Tumore (NETs). (Sub-Studie des Master-Protokolls Ipsen 001 Version 1.0: 02 Februar 2018) , Eine internationale multizentrische, offene Studie zur Bewertung der Sicherheit, Verträglichkeit, Biodistribution, Dosimetrie und der vorläufigen Wirksamkeit von 177Lu-OPS201 für die Therapie Somatostatin-Rezeptor-positiver neuroendokriner Tumore (NETs). (Sub-Studie des Master-Protokolls Ipsen 001 Version 1.0: 02 Februar 2018) , Eine internationale multizentrische, offene Studie zur Bewertung der Sicherheit, Verträglichkeit, Biodistribution, Dosimetrie und der vorläufigen Wirksamkeit von 177Lu-OPS201 für die Therapie Somatostatin-Rezeptor-positiver neuroendokriner Tumore (NETs)., Eine internationale multizentrische, offene Studie zur Bewertung der Sicherheit, Verträglichkeit, Biodistribution, Dosimetrie und der vorläufigen Wirksamkeit von 177Lu-OPS201 für die Therapie Somatostatin-Rezeptor-positiver neuroendokriner Tumore (NETs)., Eine internationale multizentrische, offene Studie zur Bewertung der Sicherheit, Verträglichkeit, Biodistribution, Dosimetrie und der vorläufigen Wirksamkeit von 177Lu-OPS201 für die Therapie Somatostatin-Rezeptor-positiver neuroendokriner Tumore (NETs). |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Participant is capable of giving signed informed consent as described in Appendix 10.1 of the Protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Participant must have received at least one infusion of 177Lu-IPN01072 in Study OPS-C-001
Exclusion criteria 1
- There are no exclusion criteria in this safety surveillance study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Presence of participants with second primary haematological and non-haematological malignancies
Secondary endpoints 3
- Incidence of treatment-related adverse events of any grade according to the National Cancer Institute–Common Terminology Criteria for Adverse Events Version 5.0, including any treatment-related serious adverse events, as assessed by the investigators
- Changes over time in laboratory tests (haematology and biochemistry)
- Overall survival defined as the time from the first dose of 177Lu-IPN01072 until death from any cause
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Satoreotide Tetraxetan LUTETIUM-177
PRD11497866 · Product
- Active substance
- Satoreotide Tetraxetan LUTETIUM-177
- Substance synonyms
- Satoreotide tetraxetan lutetium (177Lu), OPS201, Lutetium-177(3+), S2,S7-cyclo[N-{4,7,10-tricarboxymethyl-1,4,7,10-tetraaza-cyclododecan-1-yl-acetyl}-4-chloro-L-phenylalanyl-D-cysteinyl-4-[(4S)-2,6-dioxo-1,3-diazinane-4-carboxamido]-L-phenylalanyl-4-(carbamoylamino)-D-phenylalanyl-L-lysyl-L-threonyl-L-cysteinyl-D-tyrosinamide], 177Lu-SSO110, LUTETIUM-177 DOTA SATOREOTIDE, LUTETIUM-177 SATOREOTIDE TETRAXETAN, LU-177 OPS-201
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 7.4 GBq gigabecquerel(s)
- Max total dose
- 3 GBq gigabecquerel(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ARICEUM THERAPEUTICS GMBH
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/16/1754
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ariceum Therapeutics GmbH
- Sponsor organisation
- Ariceum Therapeutics GmbH
- Address
- Robert-Roessle-Strasse 10-79, Buch Buch
- City
- Berlin
- Postcode
- 13125
- Country
- Germany
Scientific contact point
- Organisation
- Ariceum Therapeutics GmbH
- Contact name
- Jürgen Fleck
Public contact point
- Organisation
- Ariceum Therapeutics GmbH
- Contact name
- Jürgen Fleck
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 3 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2022-01-06 | 2025-04-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of the Results of the Clinical Trial SUM-110831
|
2025-12-12T08:32:03 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay Person Summary of Results | 2025-12-12T08:31:49 | Submitted | Laypersons Summary of Results |
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Layman Summary_forpublication | 1 |
| Protocol (for publication) | D1_Protocol 2024-515071-35-00_for publication | 3 |
| Recruitment arrangements (for publication) | Annex_Docuement Assessed under Ctd | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF French_for publication | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF English_for publication | 1 |
| Summary of results (for publication) | Summary of the Results of the Clinical Trial_forpublication | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-12 | France | Acceptable 2024-10-07
|
2024-10-07 |