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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: Clinical Trial Phase 1 study, sponsored by Ipsen.
NCT03525392 is a Phase 1 study that was terminated before completion, run by Ipsen. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DLTs were defined for a list of predefined study medication-related adverse events (AEs) as specified in the protocol, according to the National Cancer Institute - Common Terminology Criteria for Adverse Events scale version 5.0 that occurred during the defined DLT assessment period (during Cycle 1 or 2).
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 |
Why NCT03525392 stopped before completion
NCT03525392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which 177Lu-3BP-227 (also called 177Lu-IPN01087) is the first listed.
NCT03525392 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03525392's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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