AlphaMedix for Neuroendocrine Cancer
(ALPHAMEDIX02 Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Radiomedix, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a radioactive drug called 212Pb-DOTAMTATE in adults with neuroendocrine tumors. It aims to see how well it works in patients who are either new to or have previously received similar treatments. The drug targets and kills cancer cells using radiation.

Eligibility Criteria

Adults over 18 with advanced neuroendocrine tumors (NET) that can't be removed by surgery or have spread, and who've had disease progression after previous treatments. Participants must have a life expectancy of at least 12 weeks, adequate organ function, and confirmed somatostatin receptors on their tumors. Pregnant women, those with certain heart conditions or infections like HIV/Hepatitis B/C, recent recipients of similar therapies, or individuals with uncontrolled health issues are excluded.

Inclusion Criteria

Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤3 X upper limit of normal (ULN)

My condition worsened after treatment with somatostatin analogs.

My cancer has worsened within the last year and can be measured.

+23 more

Exclusion Criteria

I have a history of myelodysplastic syndrome.

Known or suspected active drug or alcohol abuse

I have had whole-body radiotherapy or specific targeted radiation therapy.

+15 more

Participant Groups

The trial is testing AlphaMedix (212Pb-DOTAMTATE), a targeted radiotherapy for NET patients who either haven't received peptide receptor radionuclide therapy (PRRT naive) or have previously undergone PRRT. It's a Phase 2 study to see how well this treatment works in controlling the disease.

1Treatment groups

Experimental Treatment

Group I: Pb212-DOTAMTATEExperimental Treatment1 Intervention

investigational radiotherapeutic drug targeting somatostatin receptor-positive neuroendocrine tumors in PRRT naive patients (Cohort 1) and previous PRRT patients (Cohort 2)