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NCT06441331 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
A Phase 1 study of Lymphoma and Solid Tumor, sponsored by ITM Solucin.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT06441331 is a Phase 1 study of Lymphoma and Solid Tumor that is actively recruiting participants, run by ITM Solucin. The registered enrollment target is 20 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06441331, a Phase 1 study of Lymphoma and Solid Tumor, is actively recruiting participants, sponsored by ITM Solucin.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to \<18 years of age with somatostatin receptor (SSTR)-positive tumors.
Conditions Studied
Interventions
- OTHER Amino Acid Solution
- DRUG Lutetium Lu 177-Edotreotide
Study Locations (2)
Pennsylvania
- The Children's Hospital of Philadelphia (CHOP) - Philadelphia
Other
- Hospital Universitario Vall d'Hebron - Oncología Médica - Barcelona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-09-26 |
| Est. Completion | 2034-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06441331
The ClinicalTrials.gov registry entry for NCT06441331 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (96% lower). The listed sponsor is ITM Solucin, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Amino Acid Solution is the first listed.
NCT06441331 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Pennsylvania, Other.
Frequently Asked Questions
What is clinical trial NCT06441331 about?
NCT06441331 is a clinical study titled "Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors". The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to \<18 years of age with soma...
What is the current status of trial NCT06441331?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2025-09-26. Estimated completion is 2034-04.
What conditions does trial NCT06441331 study?
This clinical trial studies the following conditions: Lymphoma, Solid Tumor, Rhabdomyosarcoma, GIST, CNS Tumors.
What interventions are being tested in trial NCT06441331?
The interventions under investigation include: Amino Acid Solution (OTHER), Lutetium Lu 177-Edotreotide (DRUG).
Who is sponsoring clinical trial NCT06441331?
This trial is sponsored by ITM Solucin, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06441331 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.