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NCT03525392 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Activity (Including Distribution) of 177Lu-3BP-227 in Subjects With Solid Tumours Expressing Neurotensin Receptor Type 1.
A Phase 1 study, sponsored by Ipsen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT03525392 is a Phase 1 study that was terminated before completion, run by Ipsen. The registered enrollment target is 14 participants.
The verdict
NCT03525392, a Phase 1 study, was terminated before completion, sponsored by Ipsen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study was conducted to advance new treatment for patients with metastatic or locally advanced cancers expressing Neurotensin receptor 1 (NTSR1). This study was the first time the investigational drug called 177Lu-3BP-227 was administered to patients under controlled conditions of a clinical study. The purpose of this study was to evaluate how safe the investigational drug is as well to verify how well it is tolerated by patients after several intravenous administrations. In addition, the effect of the study drug on tumoral lesions and how it distributes throughout the body and at which rate it is removed from the body was evaluated. Since 177Lu-3BP-227 is a radio-labelled drug, it also measured how the emitted radiation is distributed throughout the body (dosimetry). The study consisted of a phase I dose escalation part. The study originally planned to include a phase II study however due to early termination (not due to safety concerns) the study did not progress to phase II and was stopped during phase I. For the phase I dose escalation part, it was anticipated that approximately 30 subjects will be included, in up to six escalation steps. No expansion cohorts were implemented.
Interventions
- DRUG 177Lu-3BP-227 (also called 177Lu-IPN01087)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-05-03 |
| Est. Completion | 2021-04-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03525392
The ClinicalTrials.gov registry entry for NCT03525392 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 177Lu-3BP-227 (also called 177Lu-IPN01087) is the first listed.
NCT03525392 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03525392 about?
NCT03525392 is a clinical study titled "Study to Evaluate the Safety and Activity (Including Distribution) of 177Lu-3BP-227 in Subjects With Solid Tumours Expressing Neurotensin Receptor Type 1.". This study was conducted to advance new treatment for patients with metastatic or locally advanced cancers expressing Neurotensin receptor 1 (NTSR1). This study was the first time the investigational drug called 177Lu-3BP-227 was administered to patients under controlled conditions of a clinical stu...
What is the current status of trial NCT03525392?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2018-05-03. Estimated completion is 2021-04-28.
What interventions are being tested in trial NCT03525392?
The interventions under investigation include: 177Lu-3BP-227 (also called 177Lu-IPN01087) (DRUG).
Who is sponsoring clinical trial NCT03525392?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
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