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177Lu-DOTA-EB-TATE in Adult Patients With Advanced, Well- Differentiated Neuroendocrine Tumors

NCT05475210 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-03-13

No results posted yet for this study

Summary

This is a Phase I clinical trial to assess the safety and dosimetry profiles of 177Lu-DOTA-EB-TATE in patients with advanced, metastatic or inoperable, somatostatin receptor-positive, well-differentiated GEP-NETs.

Conditions

Interventions

DRUG

177Lu-DOTA-EB-TATE

Peptide Receptor Radionucleotide Therapy ( PRRT) using 177Lu-DOTA-EB-TATE with a defined number of cycles will be administered.

OTHER

Amino Acid Solution

The Amino acid solution to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.

Sponsors & Collaborators

  • ClinSmart

    collaborator INDUSTRY

  • Molecular Targeting Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Lisa Bodei, MD, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-18
Primary Completion
2024-12-31
Completion
2025-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05475210 on ClinicalTrials.gov