177Lu-DOTA-EB-TATE for Neuroendocrine Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Memorial Sloan Kettering Cancer Center, New York, NY
Neuroendocrine Tumors
177Lu-DOTA-EB-TATE - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is to test a new treatment for a rare cancer. It will study how well the treatment works and what side effects it may have. The trial medication, 177Lu-DOTA-EB-TATE, is used to treat neuroendocrine tumors and is provided free of charge. This treatment has previously been approved by the FDA for a different condition. In this trial, there will be no patients receiving a placebo.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: 16-17 months

16-17 months
To determine if the maximum tolerated dose is among the explored doses of 50, 100 and 150 mCi.
To evaluate dosimetry levels in patients following 2 cycles of 177Lu-DOTA-EB-TATE.
To evaluate the differential safety of 177Lu-DOTA-EB-TATE, expressed as the number of patients with treatment-related adverse events following 177Lu-DOTA-EB-TATE.
To evaluate the safety of 177Lu-DOTA-EB-TATE assessed from the number of patients with treatment-related adverse events.
To identify the dose-limiting toxicities (DLTs) of escalating doses of 177Lu-DOTA-EB-TATE up to 150 mCi.

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Peptide Receptor Radionucleotide Therapy (PRRT)
1 of 1
Experimental Treatment

9 Total Participants · 1 Treatment Group

Primary Treatment: 177Lu-DOTA-EB-TATE · No Placebo Group · Phase 1

Peptide Receptor Radionucleotide Therapy (PRRT)Experimental Group · 2 Interventions: 177Lu-DOTA-EB-TATE, Amino Acid Solution · Intervention Types: Drug, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 16-17 months
Closest Location: Memorial Sloan Kettering Cancer Center · New York, NY
Photo of Memorial Sloan Kettering Cancer Center 1Photo of Memorial Sloan Kettering Cancer Center 2Photo of Memorial Sloan Kettering Cancer Center 3
2011First Recorded Clinical Trial
20 TrialsResearching Neuroendocrine Tumors
968 CompletedClinical Trials

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
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
10 Patients Enrolled for Neuroendocrine Tumors

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Previous local therapy (e.g.
You have histologically proven or cytologically confirmed, inoperable, GEP-NETs.
You have neuroendocrine tumors (NETs) of grade 1, 2 and 3 according to WHO 2017 classification.
You have measurable disease as defined by RECIST version 1.1.
You have at least 1 lesion with SUV greater than normal liver in at least 1 lesion.
You have a creatinine clearance > 60 mL/min.
You have a Karnofsky performance status of 70% or more.
You are of childbearing potential and you and your partner agree to use adequate contraception prior to study entry and for the duration of study participation, including follow-up (7 months after the last dose of study drug for women and 4 months for men).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.