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Radiopharmaceutical

[212Pb]VMT-alpha-NET for Neuroendocrine Tumors

Phase 1 & 2

Waitlist Available

Led By Frank I Lin, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Have received at least 1 prior systemic radioligand therapy for definitive therapeutic purposes (participants with prior external beam radiation treatment (EBRT) are also eligible)

Participants seropositive for HCV must have received curative treatment and have an undetectable HCV viral load at screening

Must not have

History of or detection at screening of active/untreated secondary malignancy except nonmelanoma skin cancer and carcinoma in situ of the uterine cervix

Timeline

Screening 3 weeks

Treatment Varies

Follow Up dlt period (through 12 weeks after initial 212pb]vmt-alpha-net administration).

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new drug called [212Pb]VMT-alpha-NET in adults with gastrointestinal neuroendocrine tumors (GI NET) or pheochromocytoma/

Who is the study for?

Adults with gastrointestinal neuroendocrine tumors or pheochromocytoma/paragangliomas that have spread and can't be surgically removed. They must have been previously treated with targeted radioligand therapy.

What is being tested?

[212Pb]VMT-alpha-NET, a drug combining a protein targeting somatostatin receptors on cancer cells with a radioactive agent to destroy them, is being tested over four 8-week cycles of infusion treatments.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, radiation exposure risks, fatigue, nausea, and other symptoms related to organ-specific inflammation due to the targeted nature of the treatment.

Eligibility Criteria

Inclusion Criteria

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

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I have had a treatment that uses radioactive substances to target cancer.

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I had hepatitis C but was treated successfully and now have no detectable virus.

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I am fully active or can carry out light work.

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I have hepatitis B but my viral load is undetectable.

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My cancer is a confirmed GI NET or PPGL and cannot be removed by surgery.

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I am 18 years old or older.

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My organs and bone marrow are functioning well.

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My tumor shows high levels of somatostatin receptor expression.

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I am HIV positive, on effective treatment, and have an undetectable viral load.

Exclusion Criteria

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

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I have no active secondary cancers except for skin cancer or cervical carcinoma in situ.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ dlt period (through 12 weeks after initial 212pb]vmt-alpha-net administration).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~dlt period (through 12 weeks after initial 212pb]vmt-alpha-net administration).

This trial's timeline: 3 weeks for screening, Varies for treatment, and dlt period (through 12 weeks after initial 212pb]vmt-alpha-net administration). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase I: MTD of [212Pb]VMT-alpha-NET using a 3+3 dose escalation design in GI NET and PPGL in a re-treatment setting

Phase II: ORR by RECIST 1.1 of participants treated with [212Pb]VMT-alpha-NET at the MTD at the completion of 4 cycles of treatment, reported by disease groups

Secondary study objectives

Dosimetry properties of [212Pb]VMT-alpha-NET via SPECT/CT, using [203Pb]VMT-alpha-NET as a surrogate with and without the administration of amino acids (Dosimetry Arm 1 only)

Overall Survival

PK properties of [212Pb]VMT-alpha-NET via blood and urine sampling

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