What side effects are associated with this type of intervention?

The most common treatments for Neuroendocrine Tumors (NETs) that target somatostatin receptors, such as 177Lu-DOTA-TATE and 177Lu-Dotatate, are generally well-tolerated but can have side effects. These include nausea, vomiting, fatigue, and mild to moderate bone marrow suppression, which can lead to anemia, thrombocytopenia, and leukopenia. Rare but serious side effects include myelodysplastic syndrome and renal toxicity. Everolimus, another systemic therapy, can cause stomatitis, infections, hyperglycemia, and pneumonitis. Somatostatin analogs like octreotide and lanreotide may cause gastrointestinal disturbances, gallstones, and injection site reactions.

What prior FDA approvals exist?

The FDA has approved 177Lu-DOTATATE (Lutathera) for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. This approval was based on the NETTER-1 trial, which demonstrated its efficacy in controlling tumor growth and improving progression-free survival. Lutathera is administered as an intravenous infusion and targets somatostatin receptors, similar to the investigational drug 177Lu-DOTA-EB-TATE being studied in the trial.

What other types of research exist?

Promising alternatives to 177Lu-DOTA-EB-TATE for neuroendocrine tumors include: 1) Radiolabeled octreotide, such as [90Y-DOTA]-TOC, which has shown long-term survival benefits in phase II trials. 2) Molecularly targeted therapies like everolimus, which targets the mTOR pathway and has demonstrated efficacy in advanced neuroendocrine tumors. 3) Multitargeted kinase inhibitors such as regorafenib, cabozantinib, sorafenib, and lenvatinib, which have shown limited activity but are still under investigation for their potential benefits.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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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.