NANETS2025 18th Annual Multidisciplinary NET Medical Symposium NANETS 2025 Clinical – Nuclear Medicine/Interventional Radiology/Imaging (22 abstracts)
[212Pb]VMT-alpha-NET for advanced SSTR+ NETs: safety and preliminary efficacy results from cohorts 1 and 2 of the dose escalation phase
Thorvadur Halfdanarson 1 , Richard Wahl 2 , Lilja Solnes 3 , Savitha Balaraman 4 , Gregory Sibley 5 , Lowell Anthony 6 , Brandon Mancini 7 , Jason Starr 8 , Vineeth Sukrithan 9 , Chih-Yi Liao 10 , Samuel Mehr 11 , Lucia Baratto 12 , Wenjing Yang 12 , Alaa Hanna 12 , Stephen Keefe 12 , Markus Puhlmann 12 & Vikas Prasad 2
1Mayo Clinic Rochester, 2Washington University School of Medicine, 3Johns Hopkins, 4Profound Clinical Research, 5Virginia Cancer Specialists, 6University of Kentucky, 7BAMF, 8Mayo Jacksonville, 9Ohio State University, 10University of Chicago, 11Nebraska Cancer Specialists, 12Perspective Therapeutics
Background: Somatostatin receptor subtype 2 (SSTR2) is expressed in neuroendocrine tumors (NETs), and it is an important target for both diagnosis and therapy. [212Pb]VMT-alpha-NET is an alpha therapy agent targeting SSTR2-expressing NETs. Here, we report the results of a prospective, open-label, Phase I/IIa clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of [212Pb]VMT-alpha-NET [NCT05636618].
Methods: Adults with well-differentiated unresectable or metastatic SSTR2-expressing NETs, who are peptide receptor radionuclide therapy (PRRT) naïve, and who progressed on at least one prior line of systemic therapy, are eligible. The study design follows a Bayesian dose-finding algorithm. Participants receive up to four doses of [212Pb]VMT-alpha-NET on 8-weeks intervals at the assigned dose level. Efficacy is assessed by investigators according to RECIST criteria v1.1.
Results: As of 30-Apr-2025, nine participants were enrolled for dose-limiting toxicity (DLT) observation into cohort 1 (n = 2) and cohort 2 (n = 7) at dose levels of 92.5 MBq [2.5 mCi] and 185 MBq [5 mCi], respectively. Thirty-three (33) additional patients were enrolled into cohort 2 to further evaluate safety and efficacy at the selected dose. Safety was assessed for all participants treated (n = 42), while efficacy was evaluated for the nine participants enrolled for DLT-observation. Among all participants treated with [212Pb]VMT-alpha-NET (n = 42), no DLTs, no grade 4 or 5 adverse events (AEs), no treatment-related discontinuations, no serious renal complications or myelosuppression, and no dysphagia were observed. Four out of seven participants (57%) enrolled for DLT-observation in cohort 2 achieved an objective response with a median follow-up time of 52 weeks (range: 6,64). Three objective responses were confirmed, while one was pending confirmation at the time of data cut-off (DCO). Overall, seven of the nine participants (78%) enrolled for DLT-observation both in cohort 1 and 2 were without progression as of the DCO, with a median follow up time of 56 weeks (range: 6,77). Cohort 3, at a dose level of 222 MBq [6 mCi], has recently been opened for enrollment. Safety data for all treated participants and efficacy results for a mature subset will be presented at the congress.
Conclusions: [212Pb]VMT-alpha-NET is a well-tolerated therapy for patients with advanced NETs, and it has shown promising clinical benefit at the dose level of 185 MBq [5 mCi]. The study is ongoing and open for enrollment in cohort 3.
Abstract ID #33440
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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