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

NCT05153772 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Alphamedix-02
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 4

Brief 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)

Conditions

Neuroendocrine Tumors

Keywords

Pb212-DOTAMTATE; alpha-emitter-therapy; neuroendocrine tumors

Outcome Measures

Primary Outcomes (2)

• 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.

  24 months after last dose administration

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

  To assess the safety and tolerability of 212Pb-DOTAMTATE

  24 months after last dose administration

Secondary Outcomes (6)

• Measurement of the Median Progression free survival (mPFS)

  24 months after last dose administration

• Measurement of Overall Survival (OS)

  24 months after last dose administration

• Measurement of Time to Tumor Progression (TTP)

  24 months after last dose administration

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

  24 months after last dose administration

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

  24 months after last dose administration

Study Arms (1)

Pb212-DOTAMTATE

EXPERIMENTAL

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

Drug: AlphaMedix

Interventions

AlphaMedix DRUG

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

Also known as: Pb212-octreotide analog

Pb212-DOTAMTATE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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);

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Orano Med LLC: lead
• Sanofi: collaborator

Study Sites (4)

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

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

Metairie, Louisiana, 70006, United States

Location

Excel Diagnostics and Nuclear Oncology Center

Houston, Texas, 77042, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: December 10, 2021
• Study Start: December 21, 2021
• Primary Completion: April 14, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)