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Radioisotope Therapy

177Lu-DOTA-EB-TATE for Neuroendocrine Cancer

Phase 1
Recruiting
Led By Lisa Bodei, MD, PhD
Research Sponsored by Molecular Targeting Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a new targeted radiation therapy for patients with advanced or hard-to-remove GEP-NETs. The therapy uses a radioactive substance that binds to cancer cells and delivers radiation directly to them.

Who is the study for?
Adults over 18 with advanced, inoperable well-differentiated neuroendocrine tumors (GEP-NETs) that are positive for somatostatin receptors can join this trial. They must have measurable disease, agree to use contraception, and have not had certain recent treatments or other cancers. People with severe organ dysfunction, active infections like hepatitis or HIV, uncontrolled diabetes, or who are pregnant/breastfeeding cannot participate.
What is being tested?
The trial is testing the safety and dosage of a new treatment called 177Lu-DOTA-EB-TATE in patients with specific types of neuroendocrine tumors. It's an early-phase study focusing on how well patients tolerate the drug and how it distributes in their bodies.
What are the potential side effects?
Potential side effects may include kidney damage due to radiation exposure from the treatment as well as typical symptoms associated with cancer therapies such as nausea, fatigue, and blood cell count changes. The exact side effects will be monitored closely given this is a Phase I trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups
Experimental Treatment
Group I: Peptide Receptor Radionucleotide Therapy (PRRT)Experimental Treatment2 Interventions
The treatment regimen will consist of a single-dose intravenous administration of 177Lu-DOTA-EB-TATE per 6-week cycle, for a total of 2 cycles. The dose per cycle will be fixed for each patient and will be escalated in 3 different dose levels, from 50 mCi to 150 mCi (1.85 -5.55 GBq). Each dose of 177Lu-DOTA-EB-TATE will be administered in association with intravenous renal protective amino acid solutions.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Neuroendocrine Tumors (NETs) include targeted radiotherapy, such as 177Lu-DOTA-EB-TATE, which works by binding to somatostatin receptors that are overexpressed on the surface of NET cells. This allows the radioactive component, Lutetium-177, to deliver targeted radiation directly to the tumor cells, minimizing damage to surrounding healthy tissue. This mechanism is crucial for NET patients as it provides a more precise treatment option, potentially leading to better outcomes and fewer side effects compared to traditional therapies. Other systemic treatments, like somatostatin analogs (e.g., octreotide, lanreotide), work by inhibiting hormone secretion and tumor growth, while molecularly targeted therapies and chemotherapy aim to disrupt specific pathways involved in tumor proliferation.

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Who is running the clinical trial?

Molecular Targeting Technologies, Inc.Lead Sponsor
2 Previous Clinical Trials
72 Total Patients Enrolled
ClinSmartIndustry Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
Lisa Bodei, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
60 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
60 Patients Enrolled for Neuroendocrine Tumors

Media Library

177Lu-DOTA-EB-TATE (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05475210 — Phase 1
Neuroendocrine Tumors Research Study Groups: Peptide Receptor Radionucleotide Therapy (PRRT)
Neuroendocrine Tumors Clinical Trial 2023: 177Lu-DOTA-EB-TATE Highlights & Side Effects. Trial Name: NCT05475210 — Phase 1
177Lu-DOTA-EB-TATE (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05475210 — Phase 1
~1 spots leftby Dec 2024