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NCT03872778 · ClinicalTrials.gov registry record · Phase 1
[177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-neoB Lesion Uptake
A Phase 1 study of Neoplasms, sponsored by Advanced Accelerator Applications.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 11
- Study locations
NCT03872778: Completed Phase 1 study of Neoplasms, sponsored by Advanced Accelerator Applications.
NCT03872778 is a Phase 1 study of Neoplasms that has completed, run by Advanced Accelerator Applications. The registered enrollment target is 35 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (98% lower). The trial reports 11 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03872778, a Phase 1 study of Neoplasms, has completed, sponsored by Advanced Accelerator Applications.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 11
- Study locations
Study Summary
First in Human (FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), distribution, radiation dosimetry, and anti-tumor activity of \[177Lu\]-NeoB in patients with advanced solid tumors known to overexpress GRPR and with \[68Ga\]-NeoB lesion uptake.
Primary Outcome
A dose-limiting toxicity (DLT) is defined as a clinically relevant adverse event or abnormal laboratory value not attributable to the disease or disease-related processes under investigation, considered possibly related to \[177Lu\]-NeoB that occurs within 42 days following the first administration of \[177Lu\]-NeoB (cycle 1) and meets any of the criteria listed in Table 6-4 (Criteria for defining dose-limiting toxicities).
Conditions Studied
Interventions
- DRUG LCZ696
- DRUG [177Lu]-NeoB
- DRUG [68Ga]-NeoB
Study Locations (11)
Other
- Medical University of Innsbruck - Innsbruck
- CHU de Grenoble - La Tronche
- Erasmus MC - Rotterdam
- Vall d'Hebron Institute of Oncology - Barcelona
- Addenbroke's hospital - Cambridge
California
- City of Hope - Duarte
- Stanford University - Stanford
Maryland
- John Hopkins University - Baltimore
Oregon
- Oregon Health & Science University - Portland
Pennsylvania
- Pittsburgh University - Pittsburgh
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2019-05-24 |
| Est. Completion | 2025-11-27 |
| Phase | Phase 1 |
What the finished NCT03872778 record still lists
NCT03872778 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which LCZ696 is the first listed.
NCT03872778 lists 11 locations in 6 states (Other, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT03872778 about?
NCT03872778 is a clinical study titled "[177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-neoB Lesion Uptake". First in Human (FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), distribution, radiation dosimetry, and anti-tumor activity of \[177Lu\]-NeoB in patients with advanced solid tumors known to overexpress GRPR and with \[68Ga\]-NeoB lesion uptake.
What is the current status of trial NCT03872778?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2019-05-24. Estimated completion is 2025-11-27.
What conditions does trial NCT03872778 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT03872778?
The interventions under investigation include: LCZ696 (DRUG), [177Lu]-NeoB (DRUG), [68Ga]-NeoB (DRUG).
Who is sponsoring clinical trial NCT03872778?
This trial is sponsored by Advanced Accelerator Applications, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03872778 being conducted?
This trial has 11 study locations across California, Maryland, Oregon, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03872778's enrollment target sits among peer trials
35 125th of 158 higher than 33 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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.
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