Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 90Years
All Genders
NCT05636618

Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors

Led by Perspective Therapeutics · Updated on 2026-05-14

300

Participants Needed

19

Research Sites

326 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is Phase I/IIa First-in-Human Study of \[212Pb\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors

CONDITIONS

Official Title

Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older with neuroendocrine tumors or meningioma confirmed by local pathology
  • Patients with locally advanced, unresectable, or metastatic NETs for dose-finding or specific NET types and meningioma for dose-expansion
  • Meningioma diagnosis confirmed by WHO classification grades 1 to 3
  • Radiological evidence of measurable disease per RECIST v1.1 for NETs or RANO meningioma criteria within specified timeframes
  • Lesions showing disease progression in the 12 months before enrollment
  • Demonstrated tumor expression of SSTR using FDA-approved PET imaging agents
  • ECOG performance status of 0 or 1
  • HIV-positive patients allowed if CD4 count is above 350 cells/μL
  • Allowed to use concurrent somatostatin analog therapy with ability to withhold therapy before treatment doses
  • Progressive disease on approved therapies other than radionuclide therapy for NETs
  • Meningioma patients on corticosteroids must have stable low dose before treatment
  • Adequate catecholamine blockade if pheochromocytoma/paraganglioma tumors are present
  • Able to understand and sign informed consent and comply with study requirements
  • Life expectancy greater than 3 months
  • Satisfactory organ function by laboratory testing
  • Females of reproductive potential must use effective contraception and avoid egg donation starting from screening until 6 months after last dose
  • Males of reproductive potential must use effective contraception and avoid sperm donation during the same period
Not Eligible

You will not qualify if you...

  • Known allergy or hypersensitivity to somatostatin analogs, SSTR imaging agents, or study drug components
  • Active additional cancers requiring treatment
  • Pregnancy or breastfeeding
  • Recent febrile illness within 48 hours of treatment
  • Use of another investigational drug within 30 days before treatment
  • Prior systemic PRRT treatment
  • Recent 90-Yttrium radioembolization within 6 months
  • Recent external beam radiation therapy within 30 days
  • Radiation dose documentation required if prior radiation treatments received
  • Recent systemic anticancer therapy within 30 days except somatostatin analogs
  • Major surgery within 30 days
  • Untreated or unstable brain metastases for NETs
  • Recent active infections requiring antifungals or antibiotics within 3 days
  • Recent live attenuated vaccines within 7 days
  • Severe nausea, vomiting, or diarrhea within 72 hours before first dose
  • Medical conditions making participation hazardous
  • History of severe allergic reactions to study drug components
  • Current abuse of alcohol or illicit drugs
  • Any medical or social issues likely to interfere with study participation
  • QTc interval longer than 450 milliseconds in males and females

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

Mayo Clinic

Jacksonville, Florida, United States, 32224

Actively Recruiting

2

Biogenix Molecular

Miami, Florida, United States, 33165

Actively Recruiting

3

The University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

4

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

5

University of Kentucky

Lexington, Kentucky, United States, 40536

Actively Recruiting

6

Johns Hopkins

Baltimore, Maryland, United States, 21287

Actively Recruiting

7

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

8

BAMF Health

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

9

Michigan Health Professionals

Troy, Michigan, United States, 48098

Actively Recruiting

10

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

11

Washington University

St Louis, Missouri, United States, 63110

Actively Recruiting

12

Nebraska Cancer Specialists

Omaha, Nebraska, United States, 68130

Actively Recruiting

13

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

14

UH Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

15

Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

16

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

17

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031

Actively Recruiting

18

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Actively Recruiting

19

Froedtert Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

C

ClinicalTrials at Perspectivetherapeutics

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors | DecenTrialz