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

Phase 1

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

Participants must have adequate organ and marrow function as defined below: Leukocytes: 3,000/microliter, Absolute Neutrophil Count: 1,500/microliter, Platelets 100,000/microliter, Hemoglobin >= 9.0 g/dL, Total bilirubin: within normal institutional limits. Note: <= 5 X institutional upper limit of normal (ULN) if bilirubin elevation is due to a benign process such as Gilbert syndrome, AST: <= 2.5 X institutional ULN, ALT: <= 2.5 X institutional ULN, Creatinine: within normal institutional limits OR Calculated creatinine clearance (glomerular filtration rate (eGFR): >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal, Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression at screening, Participants with new or progressive brain metastases or leptomeningeal disease are eligible as long as the participant is asymptomatic and not requiring medication for symptom control from the brain lesions at screening, Participants seropositive for human immunodeficiency virus (HIV) must: be on effective anti-retroviral therapy; and have an undetectable viral load at screening, Participants seropositive for hepatitis B virus (HBV), must have HBV viral load undetectable at screening, Participants seropositive for hepatitis C virus (HCV) must: received curative treatment; and have an undetectable HCV viral load at screening, Women of child-bearing potential (WOCBP) and men must agree to use an effective method of contraception (barrier, hormonal, intrauterine device [IUD], surgical sterilization, abstinence) at study entry and up to 6 months after the last dose of the study agent(s), Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6 months after the last dose of the study agents, The ability of the participant to understand and the willingness to sign a written informed consent document.

Participants must have histopathologically confirmed gastrointestinal neuroendocrine tumors (GI NET), pheochromocytoma/paraganglioma (PPGL), small cell lung cancers (SCLC), kidney cancers (KC), or Head & Neck cancers (nasopharyngeal carcinoma [NPC], olfactory neuroblastoma [ONB], sinonasal neuroendocrine carcinoma [SNEC]) that are metastatic or inoperable per Standard of Care. Note: for KC, all histopathologies of kidney cancers are eligible as long as it is a primary renal neoplasm.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, weeks 12 and 32 during treatment, every 12 weeks after that until progression or 3 years after the first [203pb]vmt-alpha-net infusion.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a study drug (\[212Pb\]VMT-Alpha-NET) on people with specific types of tumors that have high levels of certain proteins on their surface.

Who is the study for?

Adults with certain advanced cancers (lung, kidney, head and neck, digestive tract, adrenal glands) that have somatostatin receptors and can't be surgically removed. Participants must be over 18 years old with tumors that have spread to other organs.

What is being tested?

[212Pb]VMT-Alpha-NET is being tested for its effectiveness on shrinking tumors with somatostatin receptors. The drug is administered intravenously in four 8-week cycles. Some may also receive [203Pb]VMT-Alpha-NET to track the drug's distribution.

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions at the infusion site, changes in blood counts or chemistry due to the radioactive nature of treatment, fatigue from cancer therapy, and possible organ inflammation.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is one of the specified types and cannot be removed by surgery or has spread.

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I am 18 years old or older.

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I am fully active and can carry on all pre-disease activities without restriction.

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I have not had radioligand therapy but may have had external beam radiation.

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My tumor shows positive for somatostatin receptors on scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ dlts through 12 weeks after initial 212pb]vmt-alpha-net administration (dose escalation) and all toxicities from day 1 up through 3 years (dose expansion).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~dlts through 12 weeks after initial 212pb]vmt-alpha-net administration (dose escalation) and all toxicities from day 1 up through 3 years (dose expansion).

This trial's timeline: 3 weeks for screening, Varies for treatment, and dlts through 12 weeks after initial 212pb]vmt-alpha-net administration (dose escalation) and all toxicities from day 1 up through 3 years (dose expansion). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

MTD of [212Pb]VMT-alpha-NET (dose escalation cohort) and safety of [212Pb]VMT-alpha-NET at the MTD (dose expansions cohorts)

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 Response Rate

Overall Survival

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