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

Recruiting in Palo Alto (17 mi)

Overseen byFrank I Lin, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

Background: Some cancers have high levels of proteins called somatostatin receptors (SSTRs) on the surface of the tumors. These tumors can be in the lung, head and neck, digestive tract, kidneys, and in or near the adrenal glands. Researchers want to know if drug treatments that target SSTRs can help shrink these types of tumors. Objective: To test a study drug (\[212Pb\]VMT-Alpha-NET) in people with tumors that have SSTRs. Eligibility: People aged 18 years and older with tumors of the lung, kidneys, head and neck, digestive tract, or adrenal glands that have SSTRs. Their tumors must have spread to other organs and cannot be removed with surgery. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and a test of their heart function. A sample of tumor tissue may be collected if one is not already available. \[212Pb\]VMT-Alpha-NET is given through a tube attached to a needle inserted into a vein. The drug will be given on the first day of four 8-week cycles. Participants will stay in the hospital for a few nights after each dose. They will have blood tests once a week during each cycle. Some participants will also get a related study drug (\[203Pb\]VMT-Alpha-NET). They will receive this drug a few days before the first 2 cycles. At 4, 24, and 48 hours after each infusion, they will have whole body scans. These scans will show where the study drug went in their body. Follow-up visits will continue up to 6 years after the last treatment.

Research Team

Frank I Lin, M.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

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.

Inclusion Criteria

Required prior therapies: GI NET, PPGL, H&N: no specific prior therapy is needed. SCLC: At least one prior line of standard of care systemic treatment such as chemotherapy and/or immunotherapy. KC: Renal cell carcinoma (RCC) participants should have received at least one line of prior therapy in the metastatic setting and should have received at least one Programmed cell death protein 1 (PD1) / Programmed death-ligand 1 (PDL1)-targeted immune checkpoint inhibitor as well as one agent targeting the VEGF pathway. Participants with fumarate hydratase (FH) deficient RCC should have received at least one prior line of systemic therapy (such as bevacizumab plus erlotinib). No prior therapy is needed for participants with other histologic subtypes.

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

My cancer has worsened in the last 3 years, either by scans or symptoms.

See 5 more

Exclusion Criteria

Any investigational agents should be stopped at least 28 days prior to the first dose of [203Pb]VMT-Alpha-NET, Systemic therapy should be stopped at least 28 days prior to the first dose of [203Pb]VMT-Alpha-NET (participants with prior systemic therapies for their malignancy only, except participants with SCLC), Systemic therapy should be stopped at least 14 days prior to the first dose of [203Pb]VMT-Alpha-NET (participants with SCLC only), History of allergic reactions attributed to compounds of similar chemical or biologic composition to VMT-Alpha-NET, Positive Beta human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening, QTc > 450 ms on electrocardiogram (EKG) at screening. Note: Framingham correction for QTc will be used, History of or detection at screening of active/untreated secondary malignancy except nonmelanoma skin cancer and carcinoma in situ of the uterine cervix, Uncontrolled intercurrent illness, factors, evaluated by medical history and physical exam which would potentially increase in the risk of the participant.

Treatment Details

Interventions

[212Pb]VMT-Alpha-NET (Radioisotope Therapy)

Trial Overview[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.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: 3/Arm 3Experimental Treatment2 Interventions

\[212Pb\]VMT-alpha-NET at MTD

Group II: 2/Arm 2Experimental Treatment2 Interventions

Escalating doses of \[212Pb\]VMT-alpha-NET

Group III: 1/Dosimetry Arm 1Experimental Treatment3 Interventions

Escalating doses of \[212Pb\]VMT-alpha-NET, imaging with \[203Pb\]VMT-alpha-NET