Neuroendocrine Tumors UnresectablePhase 1/2NCT05636618
Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors
A Phase 1/2 study testing [203Pb]VMT-α-NET and [212Pb]VMT-α-NET in people with Neuroendocrine Tumors Unresectable and Neuroendocrine Tumor Metastatic, run by Perspective Therapeutics at 20 sites in United States.
Trial summary
This study is Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neuroendocrine Tumors Unresectable, Neuroendocrine Tumor Metastatic, Gastroenteropancreatic Neuroendocrine Tumor
- What is being tested?
- [203Pb]VMT-α-NET and [212Pb]VMT-α-NET
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 20 sitesUnited States
- Study dates
- 27 Sep 2023to 26 Dec 2029
- Phase
- Phase 1/2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (ages ≥18) PRRT-naïve subjects with NETs or meningioma by local pathology.
- Disease described clinically as: (a) Locally advanced/unresectable or metastatic NETs for dose-finding part of the study (b) Locally advanced/unresectable or metastatic GEP-NETs, bronchial NETs, pheochromocytoma, or paragangliomas for the dose-expansion part of the study (c) Requiring at least 1 prior surgery (resection/biopsy) and a maximum of 1 line of EBRT, if technically feasible, for meningioma.
- For meningioma: histologically confirmed diagnosis of meningioma, i.e., all grades (1 to 3) per World Health Organization Classification of Tumors of the Central Nervous System (5th edition; WHO-CNS5)
- Radiological evidence of measurable disease by: (a) For NETs: RECIST v1.1 criteria on CT with contrast or MRI of the areas of tumor involvement within 60 days of enrollment.
- Lesions must have shown radiological evidence of disease progression in the 12 months prior to enrollment. (b) For meningioma: RANO meningioma criteria on contrast-enhanced skull MRI for meningioma within 3 weeks prior to enrollment.
- Demonstration of lesional SSTR expression: (a) For NETs: using an FDA-approved somatostatin receptor PET imaging agent, e.g. [68Ga]DOTATATE, [64Cu]DOTATATE, or [68Ga]DOTATOC (b) For meningioma: using a standard-of-care SSTR PET imaging agent within 45 days of enrollment
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- ECOG Performance Status ≤ 1.
- Subjects with HIV positivity are allowed if CD4 Count > 350 cells/μL.
- Concurrent Somatostatin Analog (SSA) Therapy use while on protocol therapy is allowed provided that the subject must be able to tolerate withholding long-acting SSA therapy for a minimum of 28 days and short-acting SSA therapy for a minimum of 24 hours before the first and subsequent administrations of [203Pb]VMT-α-NET or [212Pb]VMT-α-NET
- For NETs: Progressive Disease on approved therapies other than radionuclide therapy.
- For subjects with meningioma who are receiving corticosteroid treatment, the dose must be ≤ 4 mg/day dexamethasone (or other corticosteroid equivalent dose) for a minimum of 7 days before the initiation of study treatment.
- Must have clinically demonstrated adequate catecholamine blockade if catecholamine-secreting pheochromocytoma/paraganglioma tumors are present.
- Able to understand and sign informed consent and comply with all study requirements.
- Life expectancy > 3 months.
- Satisfactory organ function as determined by laboratory testing.
- For females of reproductive potential: agree to use of highly effective contraception and refrain from donating eggs (ova, oocytes) for the purpose of reproduction starting from screening, during treatment, and for at least 6 months after the last dose of [212Pb]VMT-α-NET
- For males of reproductive potential: agree to use of condoms or other methods to ensure effective contraception with partner and refrain from donating sperm starting from screening, during treatment, and for at least 6 months after the last dose of [212Pb]VMT-α-NET
Who cannot join
- Known hypersensitivity to SSA, SSTR imaging agents or any of the excipients of [212Pb]VMT-α-NET.
- Known additional malignancy that is progressing or requires active treatment.
- Pregnancy or breastfeeding a child.
- Febrile illness within 48 hours of any scheduled [212Pb]VMT-α-NET administration should be rescheduled > 48 hours after resolution of fever].
- Treatment with another investigational medicinal product within 30 days of anticipated treatment.
- Prior treatment with systemic PRRT based therapies (i.e., [90Y] DOTATATE/DOTATOC or [177Lu] DOTATATE)
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- Prior treatment with 90-Yttrium radioembolization must be completed at least 6 months prior to enrollment.
- External beam radiation therapy (EBRT) must be completed at least 30 days prior to enrollment.
- Subjects who have received prior treatment with 90Y radioembolization or EBRT should have radiation absorbed dose to critical organs documented.
- Prior treatment with systemic anticancer therapy must be completed at least 30 days prior to enrollment (except for SSAs in subjects with functional tumors).
- Major surgery must be completed at least 30 days prior to enrollment.
- For Subjects with NETs: Known brain metastases; unless these metastases have been treated and stabilized 6 months prior to enrollment and the subject has been off steroid support for at least 14 days prior to enrollment.
- Recently diagnosed and active infections requiring a time-limited course of antifungals or antibiotics in the 3 days prior to enrollment.
- Receipt of live attenuated vaccines in the 7 days prior to enrollment.
- Grade 3 nausea/vomiting or diarrhea within 72 hours before the of first scheduled dose of [212Pb]VMT-α-NET despite adequate antiemetic and other supportive care
- Known medical condition which would make this protocol unreasonably hazardous for the subject.
- Medical history of a condition resulting in a severe allergic reaction such as anaphylaxis or angioedema to known components of the Investigational Medicinal Product or excipients.
- Current abuse of alcohol or illicit drugs (exclusive of use of medically prescribed cannabinoids).
- Existence of any medical or social issues likely to interfere with study conduct or that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions.
- QTc > 450 milliseconds for males and females.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
ClinicalTrials at Perspectivetherapeutics contact
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Johns Hopkins
Baltimore, Maryland, 21287
(410) 955-6785, smosall1@jhmi.edu
Seyed Ali Mosallaie, MD
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Robert Huynh, 919-445-4936, rhuynh@med.unc.edu
Jared Weiss, MD
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
(773) 702-1000, cancerclinicaltrials@bsd.uchicago.edu
Chih-Yi Liao, MD
- Recruiting
UH Cleveland Medical Center
Cleveland, Ohio, 44106
Amr Mohamed, 216-844-3951, Amr.Mohamed@UHhospitals.org
Amr Mohamed, MD
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Rajani Jacob, 614-366-3582, Rajani.Jacob@osumc.edu
Vineeth Sukrithan, M.D.
- Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Hannah Cressman, 313-576-8387, cressmanh@karmanos.org
Anthony Shields, M.D., Ph.D
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Carrie Friedman, (703)636-1473, carrie.friedman@usoncology.com
Gregory Sibley, MD
- Recruiting
BAMF Health
Grand Rapids, Michigan, 49503
BAMF Health Clinical Research Team, 616-330-2735, researchclinicalteam@bamfhealth.com
Brandon Mancini, MD
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Yusuf Menda, (319) 356-1616, yusuf-menda@uiowa.edu
(319) 356-3214
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
(904) 9532000, CANCERCTR@mayo.edu
Jason Starr, MD
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Yvonne Taul, 8593232354, yvonne.taul@uky.edu
Lowell Anthony, MD, FACP
- Recruiting
Biogenix Molecular
Miami, Florida, 33165
Jerry Joseph, 786-791-1799, jjoseph@cira-health.com
Julio Cardeo, MD
- Recruiting
Froedtert Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Dawn Carini, 414-805-0789, dcarini@mcw.edu
Alexandria Phan, MD, FACP
- Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Patient Liaison Advisor, 1-800-811-8480, cip@vumc.org
Robert Ramirez, DO
- Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Scott Degenhardt, NMAA, (402) 691-5257, sdegenhardt@nebraskacancer.com
Samuel Mehr, MD
- Recruiting
Advent Health Radiation Oncology at Central Florida
Orlando, Florida, 32804
Erin Peters, 407-303-2090, erin.peters@adventhealth.com
Ravi Shridhar, MD, PhD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Cancer Center Clinical Trials Referral Office, 855 - 776-0015, mayocliniccancertrials@mayo.edu
Thorvardur R Halfdanarson, MD
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Heather White, 206-667-5534, nucmedresearch@fredhutch.org
Angela Castellanos, MD
- Recruiting
Washington University
St Louis, Missouri, 63110
Callista Francis, 314-273-8797, francisc@wustl.edu
Richard Wahl, MD
- Recruiting
Michigan Health Professionals
Troy, Michigan, 48098
Heather Austin, 585-216-7617, heather.austin@profoundresearch.com
Savitha Balaraman, MD
About this study
Official title: A Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors
This study is Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors
Read the detailed description
This is a prospective, multi-center, open-label, radioactivity dose-finding/ dose expansion study of [212Pb]VMT-α-NET in up to approximately 300 adult subjects with unresectable or metastatic SSTR2-expressing tumors who have not received prior peptide receptor radionuclide therapy (PRRT).
Somatostatin Receptor type 2 (SSTR2) is highly expressed on various tumors including Neuroendocrine tumors (NETs), meningioma and therefore is an attractive therapeutic target. Lead-212 ([212Pb]-) based peptide-radiopharmaceuticals are an emerging class of targeted alpha-particle cancer therapies that have potential to improve delivery of a highly effective form of radiation.
[212Pb] VMT-a-NET is a targeted alpha therapy agent designed to enhance the precision and effectiveness of cancer treatment by delivering a highly potent form of radiation directly to cancer cells. This approach aims to maximize radiation delivery to tumors while minimizing exposure to healthy tissues.
The study will be conducted in 2 parts:
Part 1: Phase I Dose-Finding: Subjects will receive radioactive doses of [212Pb]VMT-α-NET for dose-limiting toxicity (DLT) observation, determining Optimal Biological Dose (OBD) and potential Recommended Phase 2 Dose (RP2D) for Part 2 (Dose Expansion). Dose changes or adjustments will be made by the safety monitoring committee (SMC) and Sponsor.
The RP2D will be determined following a holistic analysis of observed DLTs, Adverse Events (AEs), estimated cumulative organ radiation exposure, and efficacy signals over the course of all treatment cycles for all dose cohorts.
Part 2: Phase IIa Dose-Expansion: This part will enroll subjects with gastroenteropancreatic NETS, bronchial NETS, pheochromocytoma or paragangliomas, and meningioma. Subjects will receive RP2D identified in Part 1 for further assessment of safety and preliminary efficacy.
Reno-protective amino acids will be co-administered prior to each [212Pb]VMT-α-NET dose in all subjects. Dose-finding will be based on an adaptive design until optimal biologic dose is identified or the pre-specified rules are met.
A dosimetry sub-study using [203Pb]VMT-α-NET will be conducted. The subjects will undergo dosimetric evaluation prior to receiving the therapeutic agent.
- Conditions
- Neuroendocrine Tumors Unresectable, Neuroendocrine Tumor Metastatic, Gastroenteropancreatic Neuroendocrine Tumor, Bronchial Neuroendocrine Tumor, Paraganglioma, Pheochromocytoma
- Being tested
- [203Pb]VMT-α-NET, [212Pb]VMT-α-NET
- Keywords
- Radiopharmaceuticals, Somatostatin Receptor Type 2 (SSTR2), Neuroendocrine Tumors, Metastatic Neuroendocrine Tumors, Pb-212, Theranostics, Alpha Particle Therapy, Radiotherapy, [212Pb]VMT-α-NET, VMT-α-NET-T01, Pb-203, Meningioma
- Medical subject headings
- Gastro-enteropancreatic neuroendocrine tumor, Paraganglioma, Pheochromocytoma, Meningioma, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[203Pb]VMT-α-NETDrug
[203Pb]VMT-α-NET is administered by intravenous bolus injection for single-photon emission computed tomography imaging.
[212Pb]VMT-α-NETDrug
[212Pb]VMT-α-NET is administered by intravenous infusion for treatment of SSTR2 expressing tumors.
| Study group | Role | What they receive |
|---|---|---|
| Dose Finding | Experimental | Dose Finding to determine OBD and potential RP2D in up to 200 patients receiving up to 4 administrations of [212Pb]VMT-α-NET approximately 8 weeks apart.
A dosimetry sub-study utilizing [203Pb]VMT-α-NET is incorporated into the study. Receives: Drug: [203Pb]VMT-α-NET; Drug: [212Pb]VMT-α-NET |
| Dose Expansion | Experimental | Dose up to 100 subjects (gastroenteropancreatic NETs, bronchial NETs, and pheochromocytoma or paraganglioma and meningioma) at RP2D for further assessment of safety and preliminary efficacy. Receives: Drug: [203Pb]VMT-α-NET; Drug: [212Pb]VMT-α-NET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose-limiting toxicities (DLTs) after the first administration of [212Pb]VMT-α-NET
DLTs describe side effects of a drug that are serious enough to prevent an increase in dose
Measured: Incidence and severity of DLTs during the first 42 days of study treatment will be assessed.
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 in subjects with NETs
Percentage of subjects with complete responses (CRs) or partial responses (PRs) to at least 1 administration of [212Pb]VMT-α-NET
Measured: Up to week 96
ORR per Response Assessment in Neuro-Oncology (RANO) meningioma criteria in subjects with meningioma
Percentage of subjects with complete responses (CRs) or partial responses (PRs) to at least 1 administration of [212Pb]VMT-α-NET
Measured: Up to week 96
Number of subjects with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered [212Pb]VMT-α-NET and which does not necessarily have a causal relationship with this treatment. Associated Adverse Events (AE) or Serious AEs are assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Measured: Until the end of study (3 years after end-of-study visit)
Secondary outcomes (5)
Anti-tumor efficacy of [212Pb]VMT-α-NET in terms of tumor response
Determination of the best overall response rate (BOR) by RECIST v1.1 in subjects with neuroendocrine tumors or RANO in meningioma subjects
Measured: Until the end of study (3 years after end-of-study visit)
Determine the duration of response (DOR) receiving [212Pb]VMT-α-NET.
The length of time that a tumor continues to respond to treatment without the cancer growing or spreading determined by RECIST v1.1 or RANO
Measured: Up to week 96
Determination of Progression-free survival (PFS)
PFS is how long a subject lives without the disease worsening as evaluated by RECIST v1.1 or RANO
Measured: Up to week 96
To investigate the Overall Survival (OS) following treatment with [212Pb]VMT-α-NET
OS is how long a subject lives after a subject starts treatment
Measured: Until the end of study (3 years after end-of-study visit)
Determination of pharmacokinetic properties of [212Pb]VMT-α-NET.
Blood radioactivity pharmacokinetic parameter i.e. area under the plasma concentration versus time curve (AUC) is determined.
Measured: 24 hours following [212Pb]VMT-α-NET dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start27 Sep 2023
- Primary completion26 Nov 2029 (estimated)
- Study completion26 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine Tumors UnresectableStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A Phase I/IIa First-in-Human Study of \[212Pb\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perspective Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636618
- Sponsor's protocol ID
- VMT-α-NET-T101
- Status last verified
- Oct 2026
- First submitted
- 15 Nov 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Protocol, CSR
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors
- ClinicalTrials.gov ID
- NCT05636618
- Acronym / sponsor ID
- VMT-α-NET-T101
- Conditions
- Neuroendocrine Tumors Unresectable, Neuroendocrine Tumor Metastatic, Gastroenteropancreatic Neuroendocrine Tumor, Bronchial Neuroendocrine Tumor, Paraganglioma, Pheochromocytoma
- Keywords
- Radiopharmaceuticals, Somatostatin Receptor Type 2 (SSTR2), Neuroendocrine Tumors, Metastatic Neuroendocrine Tumors, Pb-212, Theranostics, Alpha Particle Therapy, Radiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Perspective TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 26 Nov 2029 (estimated)
- Study completion
- 26 Dec 2029 (estimated)
- First posted
- 5 Dec 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 study is Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors
Detailed description
This is a prospective, multi-center, open-label, radioactivity dose-finding/ dose expansion study of [212Pb]VMT-α-NET in up to approximately 300 adult subjects with unresectable or metastatic SSTR2-expressing tumors who have not received prior peptide receptor radionuclide therapy (PRRT).
Somatostatin Receptor type 2 (SSTR2) is highly expressed on various tumors including Neuroendocrine tumors (NETs), meningioma and therefore is an attractive therapeutic target. Lead-212 ([212Pb]-) based peptide-radiopharmaceuticals are an emerging class of targeted alpha-particle cancer therapies that have potential to improve delivery of a highly effective form of radiation.
[212Pb] VMT-a-NET is a targeted alpha therapy agent designed to enhance the precision and effectiveness of cancer treatment by delivering a highly potent form of radiation directly to cancer cells. This approach aims to maximize radiation delivery to tumors while minimizing exposure to healthy tissues.
The study will be conducted in 2 parts:
Part 1: Phase I Dose-Finding: Subjects will receive radioactive doses of [212Pb]VMT-α-NET for dose-limiting toxicity (DLT) observation, determining Optimal Biological Dose (OBD) and potential Recommended Phase 2 Dose (RP2D) for Part 2 (Dose Expansion). Dose changes or adjustments will be made by the safety monitoring committee (SMC) and Sponsor.
The RP2D will be determined following a holistic analysis of observed DLTs, Adverse Events (AEs), estimated cumulative organ radiation exposure, and efficacy signals over the course of all treatment cycles for all dose cohorts.
Part 2: Phase IIa Dose-Expansion: This part will enroll subjects with gastroenteropancreatic NETS, bronchial NETS, pheochromocytoma or paragangliomas, and meningioma. Subjects will receive RP2D identified in Part 1 for further assessment of safety and preliminary efficacy.
Reno-protective amino acids will be co-administered prior to each [212Pb]VMT-α-NET dose in all subjects. Dose-finding will be based on an adaptive design until optimal biologic dose is identified or the pre-specified rules are met.
A dosimetry sub-study using [203Pb]VMT-α-NET will be conducted. The subjects will undergo dosimetric evaluation prior to receiving the therapeutic agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors
| Arm | Type | Receives |
|---|---|---|
| Dose Finding | Experimental | Drug: [203Pb]VMT-α-NET, Drug: [212Pb]VMT-α-NETDose Finding to determine OBD and potential RP2D in up to 200 patients receiving up to 4 administrations of [212Pb]VMT-α-NET approximately 8 weeks apart. A dosimetry sub-study utilizing [203Pb]VMT-α-NET is incorporated into the study. |
| Dose Expansion | Experimental | Drug: [203Pb]VMT-α-NET, Drug: [212Pb]VMT-α-NETDose up to 100 subjects (gastroenteropancreatic NETs, bronchial NETs, and pheochromocytoma or paraganglioma and meningioma) at RP2D for further assessment of safety and preliminary efficacy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Adult (ages ≥18) PRRT-naïve subjects with NETs or meningioma by local pathology.
- Disease described clinically as: (a) Locally advanced/unresectable or metastatic NETs for dose-finding part of the study (b) Locally advanced/unresectable or metastatic GEP-NETs, bronchial NETs, pheochromocytoma, or paragangliomas for the dose-expansion part of the study (c) Requiring at least 1 prior surgery (resection/biopsy) and a maximum of 1 line of EBRT, if technically feasible, for meningioma.
- For meningioma: histologically confirmed diagnosis of meningioma, i.e., all grades (1 to 3) per World Health Organization Classification of Tumors of the Central Nervous System (5th edition; WHO-CNS5)
- Radiological evidence of measurable disease by: (a) For NETs: RECIST v1.1 criteria on CT with contrast or MRI of the areas of tumor involvement within 60 days of enrollment.
- Lesions must have shown radiological evidence of disease progression in the 12 months prior to enrollment. (b) For meningioma: RANO meningioma criteria on contrast-enhanced skull MRI for meningioma within 3 weeks prior to enrollment.
Key exclusion criteria (20 listed)
- Known hypersensitivity to SSA, SSTR imaging agents or any of the excipients of [212Pb]VMT-α-NET.
- Known additional malignancy that is progressing or requires active treatment.
- Pregnancy or breastfeeding a child.
- Febrile illness within 48 hours of any scheduled [212Pb]VMT-α-NET administration should be rescheduled > 48 hours after resolution of fever].
- Treatment with another investigational medicinal product within 30 days of anticipated treatment.
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 |
|---|---|---|
| [203Pb]VMT-α-NET[203Pb]VMT-α-NET is administered by intravenous bolus injection for single-photon emission computed tomography imaging. | Drug | Dose Expansion, Dose Finding |
| [212Pb]VMT-α-NET[212Pb]VMT-α-NET is administered by intravenous infusion for treatment of SSTR2 expressing tumors. | Drug | Dose Expansion, Dose Finding |
Primary outcome
Number of participants with dose-limiting toxicities (DLTs) after the first administration of [212Pb]VMT-α-NET
Time frame: Incidence and severity of DLTs during the first 42 days of study treatment will be assessed.
DLTs describe side effects of a drug that are serious enough to prevent an increase in dose
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 in subjects with NETs
Time frame: Up to week 96
Percentage of subjects with complete responses (CRs) or partial responses (PRs) to at least 1 administration of [212Pb]VMT-α-NET
ORR per Response Assessment in Neuro-Oncology (RANO) meningioma criteria in subjects with meningioma
Time frame: Up to week 96
Percentage of subjects with complete responses (CRs) or partial responses (PRs) to at least 1 administration of [212Pb]VMT-α-NET
Number of subjects with adverse events (AEs)
Time frame: Until the end of study (3 years after end-of-study visit)
Any untoward medical occurrence in a clinical investigational participant administered [212Pb]VMT-α-NET and which does not necessarily have a causal relationship with this treatment. Associated Adverse Events (AE) or Serious AEs are assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
5 secondary outcomes
Anti-tumor efficacy of [212Pb]VMT-α-NET in terms of tumor response
Time frame: Until the end of study (3 years after end-of-study visit)
Determine the duration of response (DOR) receiving [212Pb]VMT-α-NET.
Time frame: Up to week 96
Determination of Progression-free survival (PFS)
Time frame: Up to week 96
To investigate the Overall Survival (OS) following treatment with [212Pb]VMT-α-NET
Time frame: Until the end of study (3 years after end-of-study visit)
Determination of pharmacokinetic properties of [212Pb]VMT-α-NET.
Time frame: 24 hours following [212Pb]VMT-α-NET dosing.
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 13 Oct 2026.
- Individual participant dataSharing planned: Undecided. Protocol, CSR
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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.
ClinicalTrials at Perspectivetherapeutics contact
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [203Pb]VMT-α-NET and [212Pb]VMT-α-NET in people with Neuroendocrine Tumors Unresectable and Neuroendocrine Tumor Metastatic, run by Perspective Therapeutics at 20 sites 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 17 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 13 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 20 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact ClinicalTrials at Perspectivetherapeutics ((206) 676-0900, clinicaltrials@perspectivetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose-limiting toxicities (DLTs) after the first administration of [212Pb]VMT-α-NET (time frame: Incidence and severity of DLTs during the first 42 days of study treatment will be assessed.). The study lists 4 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 13 Oct 2026.