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Radioisotope Therapy

Targeted Alpha-Particle Therapy for Neuroendocrine Tumors ([212-Pb]-VMT Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Perspective Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG Performance Status 0-2

Progressive Disease on approved therapies other than radionuclide therapy.

Must not have

Known hypersensitivity to Octreotate, DOTATATE, or any of the excipients of [212Pb]VMT-α-NET

Active secondary malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 hour, 4 hours and 24 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new therapy to treat advanced neuroendocrine tumors using targeted alpha-particles.

Who is the study for?

This trial is for adults with advanced neuroendocrine tumors that show SSTR2 positivity on specific PET scans. Participants must have measurable disease progression, an ECOG Performance Status of 0-2, and a life expectancy over 3 months. Those with HIV can join if they meet certain criteria. It's not for pregnant women, those with severe recent nausea/vomiting or diarrhea, known hypersensitivity to related drugs, active secondary cancers (except stable brain metastases), or inadequate organ function.

What is being tested?

[212Pb]VMT-α-NET Targeted Alpha-Particle Therapy is being tested in this Phase I/IIa study for its effectiveness against advanced SSTR2 positive neuroendocrine tumors. The therapy aims to deliver radiation directly to the cancer cells while sparing healthy tissue.

What are the potential side effects?

Potential side effects may include typical reactions from targeted radiation therapies such as fatigue, nausea, vomiting, and localized pain where the tumor is located. Blood counts might be affected leading to increased risk of infections or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of the day.

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My condition worsened despite treatment, but I haven't had radionuclide therapy.

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My scans show positive SSTR2 using a specific PET imaging agent.

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My condition worsened despite treatment, but I haven't had radionuclide therapy.

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My cancer is advanced and cannot be removed by surgery.

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My cancer is advanced and cannot be removed by surgery.

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My adrenaline-producing tumor is under control with medication.

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I am 18 or older with a neuroendocrine tumor diagnosis.

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I am an adult with a neuroendocrine tumor diagnosed by a local pathologist.

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My scans show positive SSTR2 using a specific PET imaging agent.

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My adrenaline-producing tumor is under control with medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to Octreotate, DOTATATE, or ingredients in [212Pb]VMT-α-NET.

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I have another type of cancer that is currently active.

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I've had severe nausea, vomiting, or diarrhea in the last 3 days despite treatment.

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I completed my 90-Ytrium radioembolization treatment over 6 months ago.

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I have previously received PRRT treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 hour, 4 hours and 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 hour, 4 hours and 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour, 4 hours and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under the concentration-time curve (AUC) [Time Frame: 42 days following last dose of [212Pb]VMT-α-NET; up to 3 years

Number of participants with adverse events (AEs) [Time Frame: Through 42 days following last dose of [212Pb]VMT-α-NET; up to 3 years]

Secondary study objectives

Anti-tumor efficacy of in terms of tumor response

Biodistribution of [212Pb]VMT-α-NET using a microdose of the therapeutic surrogate, [203Pb]VMT-α-NET

Determine the duration of response (DOR) receiving [212Pb]VMT-α-NET.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion with RPh2DExperimental Treatment1 Intervention

Up to 120 patients with NET

Group II: Dose EscalationExperimental Treatment1 Intervention

Dose Escalation to determine MTD/MFD in up to 160 patients receiving up to 4 administrations of \[212Pb\]VMT-α-NET approximately 8 weeks apart. A dosimetry sub-study utilizing \[203Pb\]VMT-α-NET has been incorporated into the study.

0 / 16Eligibility criteria met