Neuroendocrine TumorsPhase 1NCT05475210
177Lu-DOTA-EB-TATE in Adult Patients With Advanced, Well- Differentiated Neuroendocrine Tumors
A Phase 1 study testing 177Lu-DOTA-EB-TATE and Amino Acid Solution in people with Neuroendocrine Tumors, run by Molecular Targeting Technologies, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 177Lu-DOTA-EB-TATE and Amino Acid Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2022to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willing to sign a written informed consent document
- Aged 18 years or older
- Histologically proven or cytologically confirmed, inoperable, GEP-NETs
- Neuroendocrine tumors (NETs) of grade 1, 2 and 3 according to World Health Organization (WHO) 2017 classification
- Measurable disease as defined by Response Criteria in Solid Tumors (RECIST) version 1.1
- Overexpression of somatostatin receptors of the target lesions in 68Ga-DOTA-TATE positron emission tomography (PET)/computed tomography (CT) with SUV of lesions greater than normal liver in at least 1 lesion
Show all 12Show fewer
- A Cockcroft Gault calculated creatinine clearance > 60 mL/min
- Karnofsky performance status scale ≥ 70%
- Women of childbearing potential and men must 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).
- Previous local therapy (e.g., chemoembolization or bland embolization) is allowed if completed >4 weeks prior to study entry.
- Previous surgery no less than 6 weeks prior to study entry.
- Either no prior treatment with 177Lu-DOTA-TATE or at least 12 months progression-free survival (PFS) after prior treatment with 177Lu-DOTA-TATE
Who cannot join
- Women who are pregnant or breastfeeding
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTA-EB-TATE as assessed from medical records
- Previous treatment with more than 4 cycles of 177Lu-DOTA-TATE
- Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 4 weeks or 4 half-lives whichever is longer, before the first administration of study drug.
- Participant has not fully recovered from major surgery or significant traumatic injury prior the first dose of study drug or expects to have major surgery during the study period or within 3 months after the last dose of study drug.
- Life expectancy < 6 months as assessed by the treating physician
Show all 23Show fewer
- > 80% liver involvement by tumor
- > 25% bone marrow involvement by tumor
- Poorly differentiated neuroendocrine neoplasms, such as poorly differentiated neuroendocrine carcinoma, small- and large-cell neuroendocrine carcinoma; mixed neuroendocrine-non-neuroendocrine neoplasm (MiNEN); Grade 3 neuroendocrine carcinomas (NEC)
- Presence of somatostatin receptor negative lesions if they cannot be addressed with loco-regional therapies prior to the treatment start
- Deteriorated renal function, as indicated by a serum creatinine clearance > 1.7 mg/dL
- Deteriorated bone marrow function
- Deteriorated liver function
- Toxicities from prior therapies that have not resolved to grade 1 or grade 0
- Active and clinically significant bacterial, fungal, or viral infection, including hepatitis B (HBV), hepatitis C (HBC), know human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness
- Known brain metastases and/or carcinomatous meningitis, unless these metastases have been treated and stabilized
- Uncontrolled diabetes mellitus as defined by a HbA1c >9%
- Impossibility to interrupt short-acting octreotide for 24 h before and 24 h after the administration of 177Lu-DOTA-EB-TATE; impossibility to have an interval of ≥4 weeks between octreotide and 177Lu-DOTA-EB-TATE
- The use of somatostatin and its analogues within 4 months of a planned 177Lu-DOTA-EB-TATE treatment
- Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Prior external beam radiation therapy involving >25% of the bone marrow
- Unmanageable urinary incontinence rendering the administration of 177Lu-DOTA-EB-TATE unsafe
- Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Phase I, Open-Label Study of the Safety and Dosimetry of a 3-Dose Regimen of Escalating Doses of 177Lu-DOTA-EB-TATE in Adult Patients With Advanced, Well- Differentiated Neuroendocrine Tumors
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
- Neuroendocrine Tumors
- Being tested
- 177Lu-DOTA-EB-TATE, Amino Acid Solution
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-DOTA-EB-TATEDrug
Peptide Receptor Radionucleotide Therapy ( PRRT) using 177Lu-DOTA-EB-TATE with a defined number of cycles will be administered.
Amino Acid SolutionOther
Also called Arginine-Lysine Solution
The Amino acid solution to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.
| Study group | Role | What they receive |
|---|---|---|
| Peptide Receptor Radionucleotide Therapy (PRRT) | Experimental | 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. Receives: Drug: 177Lu-DOTA-EB-TATE; Other: Amino Acid Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of 177Lu-DOTA-EB-TATE assessed from the number of patients with treatment-related adverse events.
Measured: 16-17 months
To identify the dose-limiting toxicities (DLTs) of escalating doses of 177Lu-DOTA-EB-TATE up to 150 mCi.
Measured: 16-17 months
To determine if the maximum tolerated dose is among the explored doses of 50, 100 and 150 mCi.
Measured: 16-17 months
Secondary outcomes (2)
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.
Measured: 16-17 months
To evaluate dosimetry levels in patients following 2 cycles of 177Lu-DOTA-EB-TATE.
Measured: 16-17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start18 Jun 2022
- Primary completion29 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molecular Targeting Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinSmart
- Responsible party
- Sponsor
- Investigators
- Lisa Bodei, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475210
- Sponsor's protocol ID
- MTTI-EBT-001
- Other IDs
- 21-362
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-Label Study of the Safety and Dosimetry of a 3-Dose Regimen of Escalating Doses of 177Lu-DOTA-EB-TATE in Adult Patients With Advanced, Well- Differentiated Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT05475210
- Acronym / sponsor ID
- MTTI-EBT-001
- Conditions
- Neuroendocrine Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Molecular Targeting Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ClinSmart
- Study start
- 18 Jun 2022 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peptide Receptor Radionucleotide Therapy (PRRT) | Experimental | Drug: 177Lu-DOTA-EB-TATE, Other: Amino Acid SolutionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ability to understand and willing to sign a written informed consent document
- Aged 18 years or older
- Histologically proven or cytologically confirmed, inoperable, GEP-NETs
- Neuroendocrine tumors (NETs) of grade 1, 2 and 3 according to World Health Organization (WHO) 2017 classification
- Measurable disease as defined by Response Criteria in Solid Tumors (RECIST) version 1.1
Key exclusion criteria (23 listed)
- Women who are pregnant or breastfeeding
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTA-EB-TATE as assessed from medical records
- Previous treatment with more than 4 cycles of 177Lu-DOTA-TATE
- Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 4 weeks or 4 half-lives whichever is longer, before the first administration of study drug.
- Participant has not fully recovered from major surgery or significant traumatic injury prior the first dose of study drug or expects to have major surgery during the study period or within 3 months after the last dose of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 177Lu-DOTA-EB-TATEPeptide Receptor Radionucleotide Therapy ( PRRT) using 177Lu-DOTA-EB-TATE with a defined number of cycles will be administered. | Drug | Peptide Receptor Radionucleotide Therapy (PRRT) |
| Amino Acid SolutionAlso: Arginine-Lysine SolutionThe Amino acid solution to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution. | Other | Peptide Receptor Radionucleotide Therapy (PRRT) |
Primary outcome
To evaluate the safety of 177Lu-DOTA-EB-TATE assessed from the number of patients with treatment-related adverse events.
Time frame: 16-17 months
To identify the dose-limiting toxicities (DLTs) of escalating doses of 177Lu-DOTA-EB-TATE up to 150 mCi.
Time frame: 16-17 months
To determine if the maximum tolerated dose is among the explored doses of 50, 100 and 150 mCi.
Time frame: 16-17 months
2 secondary outcomes
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.
Time frame: 16-17 months
To evaluate dosimetry levels in patients following 2 cycles of 177Lu-DOTA-EB-TATE.
Time frame: 16-17 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Neuroendocrine Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Bodei, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 177Lu-DOTA-EB-TATE and Amino Acid Solution in people with Neuroendocrine Tumors, run by Molecular Targeting Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of 177Lu-DOTA-EB-TATE assessed from the number of patients with treatment-related adverse events. (time frame: 16-17 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.