AlphaMedix for Neuroendocrine Cancer

(ALPHAMEDIX02 Trial)

Recruiting at 3 trial locations

Overseen By Ebrahim S Delpassand, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Radiomedix, Inc.

Must be taking: Somatostatin analogs

Must not be taking: Somatostatin analogs

Disqualifiers: Pregnancy, Brain metastases, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

69 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial requires that you stop using any somatostatin analogues, like Sandostatin® LAR, at least 28 days before starting the study, and Sandostatin® at least 1 day before. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

Is AlphaMedix safe for humans?

Initial findings from a study on [225Ac]Ac-DOTATATE, which is similar to AlphaMedix, suggest it is stable and safe for patients with neuroendocrine tumors. ^{1 2 3 4 5}

How does the drug AlphaMedix differ from other treatments for neuroendocrine cancer?

AlphaMedix, also known as Actinium-225-DOTATATE, is unique because it uses targeted alpha therapy (TAT) to deliver high-energy alpha particles directly to tumor cells, which can kill them more efficiently while sparing healthy tissue. This approach is different from traditional treatments that may not be as precise, potentially leading to more side effects. ^{1 5 6 7 8}

What data supports the effectiveness of the drug AlphaMedix for neuroendocrine cancer?

The research suggests that treatments similar to AlphaMedix, such as somatostatin analogues and peptide receptor radionuclide therapy, have shown effectiveness in stabilizing tumor growth and improving symptoms in patients with neuroendocrine tumors. Additionally, combination therapies involving somatostatin analogues have demonstrated clinical benefits. ^{1 5 7 9 10}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 212Pb-DOTAMTATE 67.6 μCi/kg dose per cycle targeting somatostatin receptor-positive neuroendocrine tumors

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and quality of life

24 months

What Are the Treatments Tested in This Trial?

Interventions

• AlphaMedix

Trial Overview 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.

How Is the Trial Designed?

Group I: Pb212-DOTAMTATE Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Radiomedix, Inc.

Lead Sponsor

Trials

7

Recruited

770+

Orano Med LLC

Lead Sponsor

Trials

4

Recruited

150+

Sanofi

Industry Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

In a study of 11 patients with grade 1/2 metastatic neuroendocrine tumors treated with [225Ac]Ac-DOTATATE, the therapy demonstrated a high disease control rate of 89%, with 44.4% of patients showing a partial response and 44.4% having stable disease.

The treatment was found to be stable and safe, with only mild toxicities reported (grade 2 renal and hematotoxicity), and a median progression-free survival of 12 months, indicating its potential effectiveness for patients who were refractory to previous treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Findings on the Use of [225Ac]Ac-DOTATATE Therapy as a Theranostic Application in Patients with Neuroendocrine Tumors. Demirci, E., Alan Selçuk, N., Beydağı, G., et al.[2023]

A meta-analysis of 2,890 patients from 17 randomized controlled trials found that nonoperative therapies for neuroendocrine tumors (NETs) significantly increase the incidence of gastrointestinal (GI) events, particularly diarrhea, nausea, and vomiting, compared to control treatments.

Specific therapies like everolimus and VEGFR inhibitors were linked to higher risks of GI issues, indicating the need for careful management of these side effects to improve patient quality of life during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of gastrointestinal events associated with nonoperative therapies for neuroendocrine tumors. Wu, Q., Chen, B., Yan, G., et al.[2020]

Actinium-225-DOTATATE, a targeted alpha therapy, shows promise in improving treatment outcomes for advanced gastro-entero-pancreatic neuroendocrine tumors due to its higher efficiency in killing tumor cells compared to lutetium-177-DOTATATE.

This therapy is considered safe because the alpha particles have a shorter path length, which minimizes damage to surrounding healthy tissue and leads to fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastro-Enteric-Pancreatic Neuroendocrine Tumor Treatment: Actinium-225-DOTATATE and Combined Therapies. Satapathy, S., Chandekar, KR., Bal, C.[2023]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Health-Related Quality of Life for Long-Acting Octreotide versus Placebo in Patients with Metastatic Midgut Neuroendocrine Tumors in the Phase 3 PROMID Trial. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Treatment efficacy in a metastatic small intestinal neuroendocrine tumour grade 2 cohort. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Biotherapies for GEP-NETs. [2022]

4. Turkey pubmed.ncbi.nlm.nih.gov

Initial Findings on the Use of [225Ac]Ac-DOTATATE Therapy as a Theranostic Application in Patients with Neuroendocrine Tumors. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The management of neuroendocrine tumours: current and future medical therapy options. [2022]

6. Poland pubmed.ncbi.nlm.nih.gov

LanroNET, a non-interventional, prospective study to assess the resource utilization and cost of lanreotide autogel 120 mg in Polish patients with neuroendocrine tumors - results of interim analysis. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of gastrointestinal events associated with nonoperative therapies for neuroendocrine tumors. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

The incidence of over-the-counter medication use in patients with midgut neuroendocrine tumors. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Gastro-Enteric-Pancreatic Neuroendocrine Tumor Treatment: Actinium-225-DOTATATE and Combined Therapies. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Chemotherapy and biotherapy in the treatment of neuroendocrine tumours. [2020]