Neuroendocrine TumorsEarly Phase 1NCT06148636
A Safety Study of 212Pb-VMT-alpha-NET in Patients With Neuroendocrine Tumors
A Early Phase 1 study testing [212Pb] VMT-α-NET and [203Pb] VMT-α-NET SPECT/CT in people with Neuroendocrine Tumors and Neuroendocrine Tumor of the Lung, run by David Bushnell at 1 site in United States.
Trial summary
This is a safety study to determine the recommended dose to test in clinical trials. The study involves two treatments with 212Pb (212-lead) VMT-α-NET. This is a safety study only; it will most likely not provide therapeutic benefit. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuroendocrine Tumors, Neuroendocrine Tumor of the Lung, Neuroendocrine Tumor Grade 1
- What is being tested?
- [212Pb] VMT-α-NET and [203Pb] VMT-α-NET SPECT/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2023to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to provide informed consent
- Stated willingness to comply with all study procedures and availability for duration of study
- Aged ≥ 18 years to 80 years at the time of study drug administration
- Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be a well-differentiated neuroendocrine tumor (i.e. grade 1 or grade 2)
- Disease not amenable to curative intent treatment (e.g., surgery) and in addition, has shown either clinical or radiographic progression on all available therapies known to confer clinical benefit in the opinion of the referring physician. If a patient is suspected of experiencing a clinical non-response to current treatment (i.e., the patients clinical symptomatology has not improved despite treatment) the patient may be included if confirmed by the study investigator.
- Prior peptide receptor radionuclide therapy (PRRT)
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- Positive somatostatin receptor (SSTR) PET/CT utilizing an FDA approved agent within 12 months prior to anticipated day 1 of treatment demonstrating SSTR positive tumor sites.
- ≥1 evaluable site of disease measuring ≥ 1.0 cm in diameter on CT or MRI as measured per RECIST
- Adequate performance status (ECOG of 0 or 1; or KPS of ≥70).
- No other active malignancy that requires immediate treatment. Slow growing concurrent cancers (such as prostate cancer) are acceptable with appropriate documentation from their treating oncologists for that primary.
- Not experiencing an uncontrolled intercurrent illness such as: infection requiring inpatient admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations, or any other condition that would limit compliance with study requirements as determined by study team members.
- Agreement to adhere to Lifestyle Considerations throughout study duration:
- During this study, participants are asked to:
- Refrain from consumption of red wine, Seville oranges, grapefruit or grapefruit juice, [pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices] from the day prior to therapy through 5 days post-treatment.
- Comply with their antihypertensive medications, if prescribed.
- Refrain from excessive alcohol use.
- Refrain from "natural" or "herbal" supplements unless approved by the treating physician and research team.
- Utilize contraception for at least 6 months in uterine-bearing patients and at least 3 months in testes-bearing patients.
Who cannot join
- Platelets < 100,000 k/mm3
- Absolute neutrophil count (ANC) of < 1500 cells/mm3
- Total bilirubin ≥ 2.5x institutional upper limit of normal for age and weight
- Aspartate aminotransferase (AST) > 2.5 x the institutional upper limit of normal
- Alanine aminotransferase (ALT)> 2.5 x the institutional upper limit of normal
- eGFR < 50 mL/min/1.73 m2 (using the Cockcroft Gault formula)
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- Proteinuria grade 2 (i.e., ≥ 3+ proteinuria)
- Individuals who are pregnant or breast feeding. A pregnancy test will be administered to individuals of child-bearing potential (per institutional policies) at screening. Participants must agree to pregnancy tests prior to each administration of a radionuclidic agent for this study.
- Individuals of reproductive potential who decline to use effective contraception through the study. Contraception should only be stopped after a conversation with the attending oncologist.
- Lactating individuals who decline to withhold breastfeeding their child. Participants may not breast feed during this study and should only resume after the study in consultation with their oncologist.
- Patient with increased fall risk in the opinion of healthcare professionals
- Therapy (including radiation therapy) within 2 calendar weeks of the start of study therapy. (Toxicities from prior therapies should have resolved to ≤ CTCAE grade 1 or a new baseline established).
- Therapeutic investigational drug within 4 weeks of C1D1 (imaging agents are acceptable)
- History of congestive heart failure and cardiac ejection fraction ≤ 40%
- Patients for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk.
- Long-acting somatostatin analogue treatment ≤ 14 days of C1D1
- Prior external beam radiation dose of >16 Gy to the kidneys.
- Prior external beam radiation (including brachytherapy) involving 25% of the bone marrow (excluding scatter doses of ≤ 5 Gy) as estimated by a radiation oncologist.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 90Y-DOTA-tyr3-Octreotide, Octreoscan®, or 68Ga-Octreotide.
Trial locations and contacts
1 site in 1 country.
United States1 site
Holden Comprehensive Cancer Center at the University of Iowa
Iowa City, Iowa, 52242
About this study
Official title: A Phase 1, First-in-human Clinical Trial of [212Pb] VMT-alpha-NET Using a Forward Dosimetric Planning Technique to Treat Refractory or Relapsed Neuroendocrine Tumors
This is a safety study to determine the recommended dose to test in clinical trials. The study involves two treatments with 212Pb (212-lead) VMT-α-NET. This is a safety study only; it will most likely not provide therapeutic benefit.
Read the detailed description
This research study is designed to explore if a new radiotherapeutic (radioactive) drug, named 212Pb (212-lead) VMT-α-NET, works against neuroendocrine tumor cells. To begin researching this drug, we need to determine if [212Pb] VMT-α-NET is safe and tolerable when used as a cancer treatment. As a safety study, it is unknown if the treatment is safe or effective.
The study will also estimate the radiation dose to the kidneys for this treatment. To calculate this radiation dose, imaging is also performed with the sister drug, [203Pb] VMT-α-NET using SPECT/CT imaging. Each participant is assigned a radiation dose to the kidneys that cannot be exceeded. The study is testing the safety of the specific radiation dose to the kidneys when using [212Pb] VMT-α-NET.
Participants are assigned a radiation dose based on how other participants have tolerated the [212Pb] VMT-α-NET. The amount of [212Pb] VMT-α-NET administered varies person-to-person because of each person's unique tumor uptake of [203Pb] VMT-α-NET and how long it lasts in the body.
The study involves 2 treatments, about 8 to 10 weeks apart. The drug is given by infusion once per treatment. The participants also receive an infusion of amino acids to help protect the kidneys as well as medications to help protect against nausea (feeling sick to the stomach).
Once a participant is administered the [212Pb] VMT-α-NET, they must be followed (i.e. come back to the clinic) for at least 6 months for safety assessments. Safety assessments include blood tests to check bone marrow, kidney, and liver function as well as urinary tests to check kidney function. Participants will also have imaging at 6 months post-treatment to measure how their tumors responded to therapy.
Participants will have lifelong follow-up for this study.
- Conditions
- Neuroendocrine Tumors, Neuroendocrine Tumor of the Lung, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2, Neuroendocrine Tumor of Pancreas
- Being tested
- [212Pb] VMT-α-NET, [203Pb] VMT-α-NET SPECT/CT
- Keywords
- alpha therapy, recurrent disease, theranostics, nuclear medicine
- Medical subject headings
- Neuroendocrine Tumors, Adenoma, Islet Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[212Pb] VMT-α-NETDrug
Up to 2 infusions with [212Pb] VMT-α-NET, each infusion separated by at least 8 weeks. During each infusion, the participants also receive an infusion with lysine and arginine (amino acids) to help reduce kidney damage.
[203Pb] VMT-α-NET SPECT/CTDiagnostic test
The [203Pb] VMT-α-NET SPECT/CT is performed for all participants to determine trial eligibility as well as for the calculations to determine the estimated radiation dose to kidneys. This involves three imaging sessions of about 2 hours each over 2 days. The participants also receive an infusion with lysine and arginine (amino acids) to help reduce kidney damage at the time they receive the injection of . [203Pb] VMT-α-NET, a radioactive tracer drug.
| Study group | Role | What they receive |
|---|---|---|
| -1 Dose Level | Experimental | This dose level is used if the starting dose level is deemed to have unacceptable toxicity.
Participants are prescribed [212Pb] VMT-α-NET with the total radiation dose to kidneys not to exceed 200 cGy. Receives: Drug: [212Pb] VMT-α-NET; Diagnostic Test: [203Pb] VMT-α-NET SPECT/CT |
| Cohort 1 | Experimental | This is the starting dose level for participants. Participants are prescribed [212Pb] VMT-α-NET with the total radiation dose to kidneys not to exceed 350 cGy. Receives: Drug: [212Pb] VMT-α-NET; Diagnostic Test: [203Pb] VMT-α-NET SPECT/CT |
| Cohort 2 | Experimental | If the participants from Cohort 1 tolerate therapy, new participants are enrolled and are prescribed [212Pb] VMT-α-NET with the total radiation dose to kidneys not to exceed 600 cGy. Receives: Drug: [212Pb] VMT-α-NET; Diagnostic Test: [203Pb] VMT-α-NET SPECT/CT |
| Cohort 3 | Experimental | If the participants from Cohort 2 tolerate therapy, new participants are enrolled and are prescribed [212Pb] VMT-α-NET with the total radiation dose to kidneys not to exceed 810 cGy. Receives: Drug: [212Pb] VMT-α-NET; Diagnostic Test: [203Pb] VMT-α-NET SPECT/CT |
| Cohort 4 | Experimental | If the participants from Cohort 3 tolerate therapy, new participants are enrolled and are prescribed [212Pb] VMT-α-NET with the total radiation dose to kidneys not to exceed 1050 cGy. Receives: Drug: [212Pb] VMT-α-NET; Diagnostic Test: [203Pb] VMT-α-NET SPECT/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine recommended therapeutic dose of [212Pb] VMT-α-NET
Determine the recommended phase 2 dose for therapy with [212Pb]VMT-Α-NET administered intravenously to patients with neuroendocrine tumors that have progressed despite therapy.
Measured: From study day 1 through 6 months post-treatment
Secondary outcomes (2)
Objective Response Rate (ORR)
Determine objective response rate using the standardized technique (RECISTv1.1) in patients with treatment refractory neuroendocrine tumors (NETs) when treated with [212Pb] VMT-α-NET. Objective response rate is the incidence of complete response and partial response added together.
Measured: At 6 months post-treatment
Maximum tolerated radiation dose for kidneys
Determine the maximum tolerated critical organ dose limit for kidneys for therapy with [212Pb]VMT-α-NET administered intravenously to patients with neuroendocrine tumors that have progressed despite therapy.
Maximum tolerated radiation dose is indicated by the number and severity of renal (i.e. kidney) toxicities observed through 12 months post-treatment.
Measured: From study day 1 through 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start10 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3 + 3 dose escalation
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Bushnell
- Sponsor type
- University, hospital or other
- Collaborators
- Holden Comprehensive Cancer Center, National Cancer Institute (NCI), Perspective Therapeutics
- Responsible party
- Sponsor-investigator, David Bushnell, University of Iowa
- Investigators
- David Bushnell, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148636
- Sponsor's protocol ID
- 202206110
- Other IDs
- R01CA243014
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2023
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A HIPAA limited dataset will be shared with requestors for each participant who has provided consent to data sharing. Data will represent critical and / or key data for primary and secondary objectives. Codebook defining data, as well as the protocol, consent, and statistical analysis plan will also be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-human Clinical Trial of [212Pb] VMT-alpha-NET Using a Forward Dosimetric Planning Technique to Treat Refractory or Relapsed Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT06148636
- Acronym / sponsor ID
- 202206110
- Conditions
- Neuroendocrine Tumors, Neuroendocrine Tumor of the Lung, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2, Neuroendocrine Tumor of Pancreas
- Keywords
- alpha therapy, recurrent disease, theranostics, nuclear medicine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- David BushnellUniversity, hospital or other
- Collaborators
- Holden Comprehensive Cancer Center, National Cancer Institute (NCI), Perspective Therapeutics
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Nov 2023 (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 safety study to determine the recommended dose to test in clinical trials. The study involves two treatments with 212Pb (212-lead) VMT-α-NET. This is a safety study only; it will most likely not provide therapeutic benefit.
Detailed description
This research study is designed to explore if a new radiotherapeutic (radioactive) drug, named 212Pb (212-lead) VMT-α-NET, works against neuroendocrine tumor cells. To begin researching this drug, we need to determine if [212Pb] VMT-α-NET is safe and tolerable when used as a cancer treatment. As a safety study, it is unknown if the treatment is safe or effective.
The study will also estimate the radiation dose to the kidneys for this treatment. To calculate this radiation dose, imaging is also performed with the sister drug, [203Pb] VMT-α-NET using SPECT/CT imaging. Each participant is assigned a radiation dose to the kidneys that cannot be exceeded. The study is testing the safety of the specific radiation dose to the kidneys when using [212Pb] VMT-α-NET.
Participants are assigned a radiation dose based on how other participants have tolerated the [212Pb] VMT-α-NET. The amount of [212Pb] VMT-α-NET administered varies person-to-person because of each person's unique tumor uptake of [203Pb] VMT-α-NET and how long it lasts in the body.
The study involves 2 treatments, about 8 to 10 weeks apart. The drug is given by infusion once per treatment. The participants also receive an infusion of amino acids to help protect the kidneys as well as medications to help protect against nausea (feeling sick to the stomach).
Once a participant is administered the [212Pb] VMT-α-NET, they must be followed (i.e. come back to the clinic) for at least 6 months for safety assessments. Safety assessments include blood tests to check bone marrow, kidney, and liver function as well as urinary tests to check kidney function. Participants will also have imaging at 6 months post-treatment to measure how their tumors responded to therapy.
Participants will have lifelong follow-up for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 3 + 3 dose escalation
| Arm | Type | Receives |
|---|---|---|
| -1 Dose Level | Experimental | Drug: [212Pb] VMT-α-NET, Diagnostic Test: [203Pb] VMT-α-NET SPECT/CTThis dose level is used if the starting dose level is deemed to have unacceptable toxicity. Participants are prescribed [212Pb] VMT-α-NET with the total radiation dose to kidneys not to exceed 200 cGy. |
| Cohort 1 | Experimental | Drug: [212Pb] VMT-α-NET, Diagnostic Test: [203Pb] VMT-α-NET SPECT/CTThis is the starting dose level for participants. Participants are prescribed [212Pb] VMT-α-NET with the total radiation dose to kidneys not to exceed 350 cGy. |
| Cohort 2 | Experimental | Drug: [212Pb] VMT-α-NET, Diagnostic Test: [203Pb] VMT-α-NET SPECT/CTIf the participants from Cohort 1 tolerate therapy, new participants are enrolled and are prescribed [212Pb] VMT-α-NET with the total radiation dose to kidneys not to exceed 600 cGy. |
| Cohort 3 | Experimental | Drug: [212Pb] VMT-α-NET, Diagnostic Test: [203Pb] VMT-α-NET SPECT/CTIf the participants from Cohort 2 tolerate therapy, new participants are enrolled and are prescribed [212Pb] VMT-α-NET with the total radiation dose to kidneys not to exceed 810 cGy. |
| Cohort 4 | Experimental | Drug: [212Pb] VMT-α-NET, Diagnostic Test: [203Pb] VMT-α-NET SPECT/CTIf the participants from Cohort 3 tolerate therapy, new participants are enrolled and are prescribed [212Pb] VMT-α-NET with the total radiation dose to kidneys not to exceed 1050 cGy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Ability to understand and willingness to provide informed consent
- Stated willingness to comply with all study procedures and availability for duration of study
- Aged ≥ 18 years to 80 years at the time of study drug administration
- Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be a well-differentiated neuroendocrine tumor (i.e. grade 1 or grade 2)
- Disease not amenable to curative intent treatment (e.g., surgery) and in addition, has shown either clinical or radiographic progression on all available therapies known to confer clinical benefit in the opinion of the referring physician. If a patient is suspected of experiencing a clinical non-response to current treatment (i.e., the patients clinical symptomatology has not improved despite treatment) the patient may be included if confirmed by the study investigator.
Key exclusion criteria (19 listed)
- Platelets < 100,000 k/mm3
- Absolute neutrophil count (ANC) of < 1500 cells/mm3
- Total bilirubin ≥ 2.5x institutional upper limit of normal for age and weight
- Aspartate aminotransferase (AST) > 2.5 x the institutional upper limit of normal
- Alanine aminotransferase (ALT)> 2.5 x the institutional upper limit of normal
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 |
|---|---|---|
| [212Pb] VMT-α-NETUp to 2 infusions with [212Pb] VMT-α-NET, each infusion separated by at least 8 weeks. During each infusion, the participants also receive an infusion with lysine and arginine (amino acids) to help reduce kidney damage. | Drug | -1 Dose Level, Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| [203Pb] VMT-α-NET SPECT/CTThe [203Pb] VMT-α-NET SPECT/CT is performed for all participants to determine trial eligibility as well as for the calculations to determine the estimated radiation dose to kidneys. This involves three imaging sessions of about 2 hours each over 2 days. The participants also receive an infusion with lysine and arginine (amino acids) to help reduce kidney damage at the time they receive the injection of . [203Pb] VMT-α-NET, a radioactive tracer drug. | Diagnostic test | -1 Dose Level, Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Determine recommended therapeutic dose of [212Pb] VMT-α-NET
Time frame: From study day 1 through 6 months post-treatment
Determine the recommended phase 2 dose for therapy with [212Pb]VMT-Α-NET administered intravenously to patients with neuroendocrine tumors that have progressed despite therapy.
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: At 6 months post-treatment
Maximum tolerated radiation dose for kidneys
Time frame: From study day 1 through 12 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Individual participant dataSharing planned: Yes. A HIPAA limited dataset will be shared with requestors for each participant who has provided consent to data sharing. Data will represent critical and / or key data for primary and secondary objectives. Codebook defining data, as well as the protocol, consent, and statistical analysis plan will also be shared.
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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.
David Bushnell, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [212Pb] VMT-α-NET and [203Pb] VMT-α-NET SPECT/CT in people with Neuroendocrine Tumors and Neuroendocrine Tumor of the Lung, run by David Bushnell 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 18 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Determine recommended therapeutic dose of [212Pb] VMT-α-NET (time frame: From study day 1 through 6 months post-treatment). 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 4 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.