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

Conditions

• Bronchial Neuroendocrine Tumor
• Gastroenteropancreatic Neuroendocrine Tumor
• Meningioma
• Neuroendocrine Tumor Metastatic
• Neuroendocrine Tumors Unresectable
• Paraganglioma
• Pheochromocytoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• [203Pb]VMT-α-NET — DRUG
  \[203Pb\]VMT-α-NET is administered by intravenous bolus injection for single-photon emission computed tomography imaging.
• [212Pb]VMT-α-NET — DRUG
  \[212Pb\]VMT-α-NET is administered by intravenous infusion for treatment of SSTR2 expressing tumors.

Study Details

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

Key Dates

Start date

Sep 27, 2023

Status verified

May 2026

Primary completion

Nov 26, 2029

Completion

Dec 26, 2029

Study Design

Enrollment

300 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Finding
  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.
• Experimental: Dose Expansion
  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.

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. ]

Central Contacts

• ClinicalTrials at Perspectivetherapeutics
  (206) 676-0900
  [email protected]

Locations (19)

Find similar trials in Jacksonville, FL

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