Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors
This study is testing a new targeted alpha-particle therapy called [212Pb]VMT-α-NET for people with advanced neuroendocrine tumors (NETs) or meningioma that have a specific marker called SSTR2. This treatment aims to deliver radiation directly to cancer cells while limiting harm to healthy tissues. Researchers will also use [203Pb]VMT-α-NET for imaging. The study will enroll up to 300 adults, aged 18 to 90, who have not had a similar type of radiation therapy before. The main goals are to find a safe dose of [212Pb]VMT-α-NET and see how well it shrinks tumors. The study is currently in an unclear status regarding recruitment.
- Study design
- This is a Phase I/IIa, multi-center, open-label study designed to find the best dose and then expand to more participants. It will enroll up to 300 adults.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 96 weeks (about 2 years) to assess how well the treatment works.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors
At a glance
Conditions
Where it's being run
19 sites across 15 statesWho to contact
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What this trial measures
- Number of participants with dose-limiting toxicities (DLTs) after the first administration of [212Pb]VMT-α-NETIncidence 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 NETsUp 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 meningiomaUp 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)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.