AlphaMedix for Neuroendocrine Cancer

(ALPHAMEDIX02 Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AlphaMedix for individuals with neuroendocrine tumors that have somatostatin receptors. The trial aims to evaluate AlphaMedix's effectiveness in those who have either never received peptide receptor radionuclide therapy (PRRT) or require additional treatment after previous PRRT. Individuals with neuroendocrine cancer that has not responded well to past treatments and can confirm the presence of specific receptors in their tumors through recent imaging may find this trial suitable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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 there any evidence suggesting that AlphaMedix is likely to be safe for humans?

Research shows that AlphaMedix (212Pb-DOTAMTATE) is being tested as a treatment for neuroendocrine tumors. Studies have found that most patients tolerate the treatment well, indicating a manageable safety profile. Both groups in the study—those new to this therapy and those previously treated—experienced similar safety outcomes. The treatment met safety standards in these studies, suggesting it is generally well-tolerated. However, since it remains in clinical trials, not all possible side effects may be known yet. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for neuroendocrine cancer, which often involve chemotherapy or surgery, AlphaMedix uses a novel approach by targeting somatostatin receptor-positive tumors with a radiotherapeutic drug called Pb212-DOTAMTATE. This drug is particularly exciting because it offers a targeted attack on cancer cells, potentially reducing damage to healthy tissues compared to traditional therapies. Researchers are hopeful that AlphaMedix can provide a more effective option for both patients who haven't undergone peptide receptor radionuclide therapy (PRRT) and those who have, thanks to its innovative mechanism of action.

What evidence suggests that AlphaMedix might be an effective treatment for neuroendocrine cancer?

Research has shown that AlphaMedix (212Pb-DOTAMTATE), the investigational treatment in this trial, may effectively treat neuroendocrine tumors. Studies found that about 60% of patients responded positively to the treatment, while many others maintained stable disease. In one study, 47.2% of patients with certain tumor types showed a confirmed positive response. These results suggest that AlphaMedix can effectively target neuroendocrine tumors with specific receptors, especially in patients who haven't received similar treatments before. Although initial findings are promising, it remains an experimental therapy. ^{1 2 3 6 7}

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

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]

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]

Citations

1. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-10-08-05-00-00-3163053

Press Release: AlphaMedixTM (212Pb-DOTAMTATE) ... AlphaMedixTM (212Pb-DOTAMTATE) achieved all primary efficacy endpoints in phase 2 study, demonstrating clinically meaningful benefits in ...

2. netrf.org netrf.org/2025/10/17/alphamedix-phase-2/

AlphaMedix™ Shows Promising Phase 2 Results in ... While the results are encouraging, AlphaMedix is still an investigational therapy and has not yet been approved for use outside of clinical ...

3. oranomed.com oranomed.com/en/resources/news/2025/alphamedixtm-212pb-dotamtate-achieved-all-primary-efficacy-endpoints-in-phase-2-study

AlphaMedixTM (212Pb-DOTAMTATE) achieved all primary ... AlphaMedix™ (212Pb-DOTAMTATE) achieved all primary efficacy endpoints in phase 2 study, demonstrating clinically meaningful benefits in patients ...

4. targetedonc.com targetedonc.com/view/dr-strosberg-highlights-positive-212pb-dotamtate-data-in-gep-nets

Dr Strosberg Highlights Positive 212Pb-DOTAMTATE Data ... And the overall response rate was actually quite impressive. It was approximately 60% and most of the other patients had stable disease as best ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.4020

Safety, tolerability and efficacy of 212Pb-DOTAMTATE as a ... Results: In cohort 1, 17 out of 36 subjects with metastatic SSTR+ GEP-NETs achieved a confirmed response (ORR 47.2% (32.0-63.0%)). In the Phase ...

6. targetedonc.com targetedonc.com/view/efficacy-safety-of-212pb-dotamtate-in-prrt-naive-patients-with-gep-nets

Efficacy, Safety of 212Pb-DOTAMTATE in PRRT-Naive ... A groundbreaking study reveals promising efficacy and safety of 212Pb-DOTAMTATE for treating neuroendocrine tumors, paving the way for future ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05153772

NCT05153772 | Targeted Alpha-emitter Therapy of PRRT ... ... Safety and Effectiveness of 212Pb-DOTAMTATE in Subjects With Somatostatin Receptor Expressing Neuroendocrine Tumors. Conditions. Neuroendocrine Tumors.