A long-term safety surveillance study in participants previously treated with 177Lu-IPN01072

A Multicentre Surveillance Study to Evaluate the Long-term Safety in Participants who Have Been Previously Treated with 177Lu-IPN01072 in an Ipsen-sponsored Clinical Study

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003640-88-AT

Enrollment

Registered

2021-06-15

Start date

2022-01-26

Completion date

Unknown

Last updated

2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine tumors (NETs) MedDRA version: 21.0 Level: PT Classification code 10052399 Term: Neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: 177Lu-satoreotide tetraxetan Product Code: 177Lu-SSO110, 177Lu-IPN01072,177Lu-OPS201 Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A CAS Number: 14265-75-9 Current S

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: (1) 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. (2) Participant must have received at least one infusion of 177Lu-IPN01072 in Study OPS-C- 001 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 19 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19

Exclusion criteria

Exclusion criteria: There are no exclusion criteria in this safety surveillance study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the incidence of second primary haematological and non-haematological malignancies;Secondary Objective: • To evaluate the long-term safety profile of 177Lu-IPN01072 • To evaluate the overall survival;Primary end point(s): Presence of participants with second primary haematological and non-haematological malignancies;Timepoint(s) of evaluation of this end point: Screening Visit, Safety Follow-up Period Every 3 Months, end of study / early withdrawal visit	—

Measure

Time frame

Main Objective: To assess the incidence of second primary haematological and non-haematological malignancies;Secondary Objective: • To evaluate the long-term safety profile of 177Lu-IPN01072 • To evaluate the overall survival;Primary end point(s): Presence of participants with second primary haematological and non-haematological malignancies;Timepoint(s) of evaluation of this end point: Screening Visit, Safety Follow-up Period Every 3 Months, end of study / early withdrawal visit

—

Secondary

Measure	Time frame
Secondary end point(s): • 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;Timepoint(s) of evaluation of this end point: Screening Visit, Safety Follow-up Period Every 3 Months, end of study / early withdrawal visit	—

Measure

Time frame

Secondary end point(s): • 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;Timepoint(s) of evaluation of this end point: Screening Visit, Safety Follow-up Period Every 3 Months, end of study / early withdrawal visit

—

Countries

Australia, Austria, Canada, Denmark, France, Switzerland, United Kingdom

Contacts

Public ContactJürgen Fleck

Ariceum Therapeutics GmbH

j.fleck@ariceum-therapeutics.com+41 78 3005799

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026