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Clinical Trial: [212Pb]VMT-α-NET Alpha-emitter – Phase 1/2a Clinical Trial

Clinical Trial: [212Pb]VMT-α-NET Alpha-emitter – Phase 1/2a Clinical Trial

Update 21 June 2025. Perspective Therapeutics Commences Recruitment for [212Pb]VMT-α-NET in the Third Dose Escalation Cohort of its Ongoing Phase 1/2a Clinical Trial

June 21, 2025

  • [212Pb]VMT-α-NET Phase 1/2a study is advancing into Cohort 3 with a fixed administered dose that is up to 20% higher (6 mCi) than the dose administered to patients in Cohort 2
  • Dosimetry sub-study analysis presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2025 Annual Meeting to advance utility of dosimetry in clinical development when considered with clinical data
  • On track to submit further clinical updates to scientific congresses in 2H 2025, including longer safety follow-up on all patients who have received at least one treatment of [212Pb]VMT-α-NET and anti-tumour activities in patients dosed to date who have had the opportunity to receive at least one scan after their full treatment. Read more here

Perspective Therapeutics to Pursue Dose Escalation of [212Pb]VMT-α-NET in its Ongoing Phase 1/2a Clinical Trial Based on Data Presented at the 2025 ASCO Symposium/ASCO GI
 January 24, 2024

  • Key findings include:– The treatment continued to demonstrate a favourable safety profile, with no dose-limiting toxicities observed at the two tested doses of 2.5 mCi and 5.0 mCi.– In Cohort 2, three out of seven patients experienced objective responses as defined by RECIST v1.1, including one confirmed response that has been ongoing for 17 weeks.

    — Five patients from Cohorts 1 and 2 who had stable disease at earlier assessments remain in stable disease.

    Perspective Therapeutics is progressing with dose escalation in the trial, with the next step being Cohort 3. The company is engaging with the FDA for alignment on the next phase of the study

Read the whole summary by clicking here.

Perspective Therapeutics Announces First Neuroendocrine Tumor Patients Dosed with Therapeutic Intent

November 8, 2023

SEATTLE, Nov. 08, 2023 (GLOBE NEWSWIRE) — Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), announced today that the first patient was dosed at Washington University in St Louis in the Company’s Phase 1/2a trial evaluating the safety and efficacy of [212Pb]VMT-α-NET, a targeted alpha-particle therapy (TAT), in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2) expressing neuroendocrine tumours (NETs) – including Pheochromocytomas and Paragangliomas and metastatic Neuroendocrine Carcinomas where applicable.

The trial is a multi-centre, open-label dose escalation, dose expansion study of [212Pb]VMT-α-NET in patients who have not received prior peptide receptor radionuclide therapy (PRRT).  Read announcement here

Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumours (212-Pb-VMT)

The Company’s melanoma (VMT01) and neuroendocrine tumour (VMT-𝛼-NET) programs will then commence Phase 1/2a therapy trials for the treatment of metastatic melanoma and neuroendocrine tumours at two leading academic institutions. The Company has also developed a proprietary lead-212 generator to secure isotope supply for clinical trials and commercial operations.

See clinical trial info below.

Study Start 2023-09-27Primary Completion (Estimated) 2026-09-30Study Completion (Estimated) 2028-01-31
Locations;


Clinical Trial Document can be viewed by clicking here

Other timeline events

Update 23 January 2023

In early December, VMT-α-NET, the Company’s lead drug for the treatment of neuroendocrine tumours was administered to patients in India on a compassionate use basis, independent of a planned US trial

No acute adverse reactions were observed in the first 10 days post administration and patients remain stable and in good condition

No acute adverse reactions were observed in the first 10 days post administration and patients remain stable and in good condition

Update 3 October 2023

An announcement from Viewpoint Molecular Targeting indicates the U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of [212Pb]VMT-α-NET for treatment of patients with SSTR2-positive unresectable or metastatic neuroendocrine tumours (NETs) (including GEP-NETs or bronchial NETs and pheochromocytomas and paragangliomas).

This does not mean the drug is approved for routine use, it just means the drug development has been given special treatment based on closer collaboration with FDA to ensure a smoother path when required.  Clearly the drug still needs to meet FDA criteria along the way.

Update 23 January 2023

In early December, VMT-α-NET, the Company’s lead drug for the treatment of neuroendocrine tumours was administered to patients in India on a compassionate use basis, independent of a planned US trial

No acute adverse reactions were observed in the first 10 days post administration and patients remain stable and in good condition

No acute adverse reactions were observed in the first 10 days post administration and patients remain stable and in good condition

Update 10 September 2021

Viewpoint Molecular Targeting (TM) Receives FDA Clearance of Investigational New Drug Application for Phase 1 Imaging Study for VMT-a-NET for Neuroendocrine Tumours

Edit:  This is now delayed.  The Phase 0 imaging trial precedes the therapy trial

Alpha-emitter PRRT

Some years ago I wrote about an emerging type of peptide receptor radionuclide therapy (PRRT) suggesting it could be next generation.  That work continues.  It was being labelled with the term “Targeted Alpha-emitter Therapy (TAT)” using “alpha particles”.  The current approved types of PRRT use beta particles so is a totally different method.  You might be thinking what the differences are and how does it affect me?  You can read more in my article PRRT – The Sequel? – Targeted Alpha-emitter Therapy (TAT).

PRRT – The Sequel? – Targeted Alpha-emitter Therapy (TAT)

I also wrote about the term THERANOSTICS, a combo term for THERAPY and DIAGNOSTICS.  In the same way that you have a theranostic pair in Ga68 PET and Lu177 DOTATATE/DOTATOC, alpha particle therapy will eventually need the same approach in order that specialists know the output from the diagnostic imaging, will have a therapeutic effect using alpha therapy.

So, it is good to see trials emerging along these lines.  VMT-𝛼-NET is entering a Phase 0 imaging study followed by a Phase 1 therapy study for neuroendocrine tumours at the University of Iowa.

VMT = Viewpoint Molecular Targeting (now Perspective Therapeutics)

Viewpoint Molecular Targeting is a radiopharmaceutical company developing precision oncology therapeutics and complementary diagnostic imaging agents. The Company’s proprietary technology utilizes lead-212 (i.e. 212Pb mentioned in the TAT article above) to deliver powerful alpha radiation specifically to cancer cells via specialized targeting peptides. Viewpoint is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes.   This ‘theranostic’ approach enables the ability to see the specific tumour and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments.

VMT-𝛼-NET is designed to deliver powerful alpha particle radiation specifically to the NET, while minimizing risk to normal organs and tissues. In 2019, the University of Iowa was awarded an R01 research grant from the National Cancer Institute (NCI) to prepare for and conduct an image-guided alpha-particle therapy trial of VMT-𝛼-NET for NETs. The first-in-human imaging trial was anticipated to commence in early 2021 but in April 2022, I don’t believe the trial linked below was commenced (to be confirmed). Viewpoint has further been awarded over $4M in the form of Small Business Innovation Research grants from the NCI to advance this cutting-edge treatment to clinical development. Thus, the VMT-𝛼-NET receptor-targeted alpha-particle radiotherapy is positioned to advance a new transformative treatment paradigm for NET patients.

A First-in-human Clinical Trial to Evaluate an Alpha-radiation Imaging Agent is a stepping stone to therapy trials.

This is the first-in-human study to determine if [203Pb]VMT-α-NET identifies neuroendocrine tumours with SPECT/CT. This is the first step to testing [212Pb]-based alpha radiation therapy in neuroendocrine therapy. Details of this clinical trial can be found here.

Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors (212-Pb-VMT) – Clinical Trial document

Clinical Trial Document can be viewed by clicking here

Other 212Pb clinical trials

See the Alphamedix trial by clicking here or on the picture below.

click on the picture to read more

Disclaimer

I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.

Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional. Some content may be generated by AI which can sometimes be misinterpreted.  Please check any references attached.

Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.

General Clinical Trials Disclaimer

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact.  If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net

The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.

Finally

Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product.  Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document.   Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET

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Ronny

 

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By Ronny AllanOn 3 Comments
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By Ronny Allan

Ronny Allan is a 3 x award-winning accredited patient leader advocating internationally for Neuroendocrine Cancer and all other cancer patients generally. Check out his Social Media accounts including Facebook, BlueSky, WhatsApp, Instagram and and X.

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