Study on Targeted Alpha-Particle Therapy for Advanced Neuroendocrine Tumors with SSTR2

Sponsor: Perspective Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05636618

Provider View

This clinical trial is testing a new treatment called [212Pb]VMT-α-NET, which uses targeted alpha-particle therapy to treat advanced neuroendocrine tumors that have a specific marker called SSTR2. The study aims to find the safest and most effective dose for patients who have not received similar treatments before.

Patient Parameters

Program Overview

This study is exploring a new treatment for advanced neuroendocrine tumors (NETs) that cannot be removed by surgery or have spread to other parts of the body. The treatment, called [212Pb]VMT-α-NET, targets tumors with a specific marker known as SSTR2. The study is divided into two phases: Phase I will test different doses to find the safest level, while Phase IIa will expand the study to more patients to see how well the treatment works. Up to 160 adults will participate, and the study will include additional safety measures to protect the kidneys during treatment.

Description

This clinical trial is designed to test a new treatment for advanced neuroendocrine tumors (NETs) that express a marker called SSTR2. The treatment, [212Pb]VMT-α-NET, uses targeted alpha-particle therapy to attack cancer cells. The study will enroll up to 160 adult patients whose tumors cannot be surgically removed or have spread to other areas. Participants must not have received prior peptide receptor radionuclide therapy (PRRT).

The study is divided into two phases. In Phase I, researchers will test up to four different doses of the treatment to find the safest level. Each dose group will include up to 8 patients, and the doses will be given about 8 weeks apart. The study will monitor for any side effects or adverse events to determine the Maximum Tolerated Dose (MTD). If the MTD cannot be identified, a Maximum Feasible Dose (MFD) will be determined based on production and logistical considerations.

In Phase IIa, the study will expand to include up to 120 more patients to further evaluate the treatment's effectiveness. This phase will include approximately 100 patients with gastroenteropancreatic NETs, 10 with bronchial NETs, and 10 with pheochromocytoma or paragangliomas. All participants will receive kidney-protective amino acids before each treatment dose to minimize potential side effects.

A lead-in dosimetry sub-study will be conducted during the dose escalation period to evaluate how the treatment is distributed in the body. This will involve dosimetric evaluation for patients in the first two dose groups before they receive the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with neuroendocrine tumors (NETs) confirmed by local pathology.
  • Tumors that are locally advanced, cannot be surgically removed, or have spread to other parts of the body.
  • Evidence of measurable disease on a CT or MRI scan within 60 days before joining the study.
  • Tumors must have shown growth in the past 12 months.
  • Tumors must express the SSTR2 marker, confirmed by a specific PET scan within 12 months before joining the study.
  • General health status must be good, with an ECOG performance score of 0 to 2.
  • HIV-positive patients are allowed if their CD4 count is above 500 cells/μL.
  • Patients can continue using somatostatin analogues if they have a functional tumor and have shown disease progression while on this therapy.
  • Must have stopped long-acting somatostatin analogues 30 days before the PET scan, if possible, and short-acting ones 24 hours before.
  • Disease must have progressed on approved therapies other than radionuclide therapy.
  • Patients with catecholamine-secreting tumors must have adequate catecholamine control.
  • Must be able to sign informed consent and follow study requirements.
  • Life expectancy must be more than 3 months.

Exclusion Criteria

  • Allergy to Octreotate, DOTATATE, or any components of [212Pb]VMT-α-NET.
  • Active secondary cancer.
  • Pregnant or breastfeeding women.
  • Fever within 48 hours before scheduled treatment.
  • Participation in another drug study within 30 days before treatment.
  • Previous treatment with systemic PRRT or certain radioembolization therapies.
  • Recent external beam radiation therapy or major surgery within 30 days before joining the study.
  • Known brain metastases unless treated and stable for 6 months before joining the study.
  • Active infections requiring treatment within 3 days before joining the study.
  • Recent live vaccine within 7 days before joining the study.
  • Severe nausea, vomiting, or diarrhea within 72 hours before the first dose.
  • Medical conditions that make the study unsafe for the patient.
  • History of severe allergic reactions to study components.
  • Current abuse of alcohol or illegal drugs.
  • Medical or social issues that interfere with the study or increase risk.
  • Abnormal heart rhythm (QTc > 450 milliseconds).
  • Abnormal blood test results, including low hemoglobin, platelet count, or neutrophil count, and poor kidney or liver function.

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