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NCT03188328 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, PK, Dosimetry, MTD and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by IV Escalating Doses of [177Lu]DOTA-biotin in Pts With Injectable Solid Tumors or Lymphomas
A Phase 1 study, sponsored by Alfasigma S.p.A..
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03188328: Clinical Trial Phase 1 study, sponsored by Alfasigma S.p.A..
NCT03188328 is a Phase 1 study that was terminated before completion, run by Alfasigma S.p.A.. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03188328, a Phase 1 study, was terminated before completion, sponsored by Alfasigma S.p.A..
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Local treatment of unresectable tumors is challenging, particularly with radioactivity. Current practice relies on external beam irradiation or on a variety of medical devices for brachytherapy. Both approaches proved useful in controlling tumor growth but are characterized by poor patient's compliance, significant side effects, high costs and technological complexity hampering wide-spread use. The use of AvidinOX for radionuclide therapy of inoperable cancer lesions will offer a number of advantages compared to current brachytherapy. In fact, the perfusion of a target tissue with AvidinOX, compared to current devices, will allow adapting the therapy to the tumor/organ shape, and it will also make it possible to delay the administration of radioactivity for several days which, according to pre-clinical studies, might be also divided up into repeated doses. AvidinOX linking stably to tissue proteins, does not exhibit the problem of seed migration which is associated with high morbidity. Based on previous findings with AvidinOX in combination with radionuclides in pre-clinical studies as well as data from the clinical use in liver metastases, it can be assumed that intralesional injections of AvidinOX followed by intravenous injections of 177Lu-ST2210 could be a safe and efficacious method for treating inoperable tumor lesions.
Interventions
- DRUG AvidinOX
- DRUG 177Lu-ST2210
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2017-08-07 |
| Est. Completion | 2019-07-01 |
| Phase | Phase 1 |
Why NCT03188328 stopped before completion
NCT03188328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which AvidinOX is the first listed.
NCT03188328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03188328 about?
NCT03188328 is a clinical study titled "Safety, Tolerability, PK, Dosimetry, MTD and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by IV Escalating Doses of [177Lu]DOTA-biotin in Pts With Injectable Solid Tumors or Lymphomas". Local treatment of unresectable tumors is challenging, particularly with radioactivity. Current practice relies on external beam irradiation or on a variety of medical devices for brachytherapy. Both approaches proved useful in controlling tumor growth but are characterized by poor patient's complia...
What is the current status of trial NCT03188328?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2017-08-07. Estimated completion is 2019-07-01.
What interventions are being tested in trial NCT03188328?
The interventions under investigation include: AvidinOX (DRUG), 177Lu-ST2210 (DRUG).
Who is sponsoring clinical trial NCT03188328?
This trial is sponsored by Alfasigma S.p.A., which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03188328's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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