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Neuroendocrine TumorsPhase 2ALPHAMEDIX02NCT05153772

Targeted Alpha-emitter Therapy of PRRT Naïve and Previous PRRT Neuroendocrine Tumor Patients

A Phase 2 study testing AlphaMedix in people with Neuroendocrine Tumors, run by Orano Med LLC at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Multicenter Phase 2 study of 212Pb-DOTAMTATE enrolling adult subjects with positive somatostatin positive neuroendocrine tumors with either no prior history of peptide receptor radionuclide therapy (PRRT naive) or prior history of peptide receptor radionuclide therapy (Previous PRRT) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Tumors
What is being tested?
AlphaMedix
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
4 sitesUnited States
Study dates
21 Dec 2021to Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female ≥18 years old with unresectable or metastatic histologically confirmed NET
  • Subjects must have received and progressed following somatostatin analog administration
  • For PRRT naive subjects, documented progression of disease following previous therapy within 12 months prior to enrollment and the presence of at least 1 site of measurable disease per RECIST 1.1
  • Subjects who previously received PRRT must have documented progression of disease and at least 1 site of measurable disease per RECIST 1.1 after receiving up to 4 doses (≤ 880 mCi) of 177Lu-DOTATATE/DOTATOC and received their last dose at least 6 months prior to Day 1
  • Confirmed presence of somatostatin receptors on all lesions including the non-target and measurable lesions documented by CT/MRI scans, based on positive 68Ga-DOTATATE (NETSPOT®), 64Cu-DOTATATE (Detectnet™), or other Food and Drug Administration (FDA) approved SSTR PET/CT imaging within 6 weeks prior to enrollment. Follow up imaging should be performed with the same agent or modality used at baseline;
  • Target lesions must be positive (greater than grade 2 uptake Krenning Score) or must have a standardized uptake value of more than the normal liver background.
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  • Lytic bone lesions, with an identifiable soft tissue component, evaluated by CT or MRI, can also be considered measurable lesions if the soft tissue component otherwise meets the definition of measurability according to RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) status 0-2;
  • Life expectancy of at least 12 weeks in the opinion of the investigator at the time of screening;
  • Sufficient bone marrow capacity and organ function in the recent blood tests within 3 weeks prior to Day 1, as defined by:
  • White blood cell (WBC) ≥2,500/ mm3;
  • Absolute neutrophil count (ANC) ≥1000/mm3;
  • Platelets ≥100,000/mm3;
  • Hemoglobin (HgB) ≥9.0 g/dL;
  • Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤3 X upper limit of normal (ULN);
  • Total Bilirubin: ≤2 X ULN;
  • Serum creatinine ≤1.7 mg/dL for PRRT naïve subjects; ≤ ULN for previous PRRT subjects;
  • Serum albumin ≥3.0 g/L; if lower than 3.0 g/L requires normal range prothrombin time (PT) and international normalized ratio (INR), and
  • Be willing to practice the following medically acceptable methods of birth control (both women of childbearing potential (WOCBP) and men who have partners of childbearing potential) from the Screening Visit through 3 months after the final administration 212Pb-DOTAMTATE

Who cannot join

  • Prior whole-body radiotherapy or PRRT using 177Lu/90Y/111In-DOTATATE/ DOTATOC or Targeted Alpha Therapy (TAT).
  • For subjects who previously received PRRT, prior treatment with: Prior treatment with 90Y- DOTATATE/ DOTATOC, 225Ac-DOTATATE/DOTATOC, and/or 111In-DOTATATE/ DOTATOC
  • Prior regional hepatic radionuclide therapy within 4 months prior to enrollment or prior nonradioactive regional hepatic therapy within 6 months prior to enrollment.
  • Known hypersensitivity to somatostatin analogues, Amino Acid infusion, or 212Pb-DOTAMTATE;
  • Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 1 day) prior to Cycle 1 Day 1;
  • History of myelodysplastic syndrome (MDS);
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  • Female subjects who are pregnant or lactating;
  • Indication for surgical lesion removal with curative potential;
  • Known brain metastases, unless these metastases have been treated and/or stable for 6 months prior to enrollment;
  • Experimental cancer treatments or other investigational therapies within 6 weeks or five half-lives of the investigational medication prior to Day 1;
  • Uncontrolled congestive heart failure (NYHA II, III, IV);
  • Uncontrolled diabetes mellitus as defined by a hemoglobin A1C >10.0;
  • Evidence of renal obstruction based on Tc-99m DTPA or TER for MAG3 renal scintigraphy or renal ultrasound.
  • Known or active human immunodeficiency virus (HIV) or hepatitis B or C virus unless cured;
  • Known or suspected active drug or alcohol abuse;
  • Participation in other interventional clinical studies within 30 days prior to Day 1;
  • Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years;
  • Any somatic or psychiatric disease/condition or abnormal laboratory test that in the opinion of the investigator, may interfere with the objectives and assessments of the study; or
  • Unable to comply with the requirements of the study protocol or be unsuitable for the study for any reason, in the opinion of the investigator.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Excel Diagnostics and Nuclear Oncology Center

    Houston, Texas, 77042

  • Louisiana State University (LSU) Health Sciences Center - New Orleans

    Metairie, Louisiana, 70006

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 2 Open Label Study to Evaluate the Safety and Effectiveness of 212Pb-DOTAMTATE in Subjects With Somatostatin Receptor Expressing Neuroendocrine Tumors

Multicenter Phase 2 study of 212Pb-DOTAMTATE enrolling adult subjects with positive somatostatin positive neuroendocrine tumors with either no prior history of peptide receptor radionuclide therapy (PRRT naive) or prior history of peptide receptor radionuclide therapy (Previous PRRT)

Read the detailed description

In this open-label, multicenter, single-arm Phase 2 study, adult subjects with histologically confirmed NETs and positive somatostatin analog imaging, with either no prior PRRT (PRRT naive) or prior history of peptide receptor radionuclide therapy (previous PRRT) will be enrolled to receive 212Pb-DOTAMTATE 67.6 μCi/kg dose per cycle

Being tested
AlphaMedix
Keywords
Pb212-DOTAMTATE, alpha-emitter-therapy, neuroendocrine tumors
Medical subject headings
Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlphaMedixDrug

    Also called Pb212-octreotide analog

    212Pb-DOTAMTATE is a radiolabeled derivative of octreotide targeting somatostatin positive neuroendocrine tumors

Study groups in NCT05153772
Study groupRoleWhat they receive
Pb212-DOTAMTATEExperimentalinvestigational radiotherapeutic drug targeting somatostatin receptor-positive neuroendocrine tumors in PRRT naive patients (Cohort 1) and previous PRRT patients (Cohort 2)
Receives: Drug: AlphaMedix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

    The morphological imaging (CT/MRI) will be done before therapy and selected time points before therapy cycle to determine changes in the size of target lesions.

    Measured: 24 months after last dose administration

  2. Number of patients with treatment-related adverse events as assessed by CTCAE v.4.0

    To assess the safety and tolerability of 212Pb-DOTAMTATE

    Measured: 24 months after last dose administration

Secondary outcomes (6)

  1. Measurement of the Median Progression free survival (mPFS)

    PFS will be defined as the number of days from the first dose of 212Pb-DOTAMTATE to documented tumor progression per RECIST 1.1 criteria or death due to any cause.

    Measured: 24 months after last dose administration

  2. Measurement of Overall Survival (OS)

    OS will be defined as the number of days from the first dose of 212Pb-DOTAMTATE to the date of death due to any cause or the date of last contact (censored observations) at the data cut-off date.

    Measured: 24 months after last dose administration

  3. Measurement of Time to Tumor Progression (TTP)

    This measurement will determine the time from start of treatment with 212Pb- DOTAMTATE until disease progression.

    Measured: 24 months after last dose administration

  4. To evaluate health-related quality of life (HRQL) using ECOG performance status

    Changes in quality of life will be assessed relative to baseline.

    Eastern Cooperative Oncology Group (ECOG) is designed to measure how cancer affects subject's daily life and is assessed using 0-5 scale.

    Measured: 24 months after last dose administration

  5. To evaluate health-related quality of life (HRQL) using HRQL questionnaire EORTC QLQ-C30

    Changes in quality of life will be assessed relative to baseline.

    European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 is a self-assessed questionnaire that consists of 30 questions designed to measure varying types of functioning, symptoms and overall health/quality of life. It is assessed using either a 4-point scale or 7-point scale, depending on the question.

    Measured: 24 months after last dose administration

  6. To evaluate health-related quality of life (HRQL) using HRQL questionnaire EORTC QLQ-G.I.NET21

    Changes in quality of life will be assessed relative to baseline.

    European Organisation for Research and Treatment of Cancer (EORTC) QLQ-G.I.NET21 is a self-assessed questionnaire that consists of 51 questions designed to assess symptoms or problems. It is assessed using a 4-point scale.

    Measured: 24 months after last dose administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2021
  2. Study start21 Dec 2021
  3. Primary completion14 Apr 2025
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05153772
Sponsor's protocol ID
Alphamedix-02
Acronym
ALPHAMEDIX02
Status last verified
Apr 2026
First submitted
4 Nov 2021
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AlphaMedix in people with Neuroendocrine Tumors, run by Orano Med LLC at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. (time frame: 24 months after last dose administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05153772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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