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Targeted Alpha-emitter Therapy of PRRT Naive Neuroendocrine Tumor Patients (ALPHAMEDIX02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05153772
Recruitment Status : Recruiting
First Posted : December 10, 2021
Last Update Posted : January 10, 2022
Orano Med LLC
Information provided by (Responsible Party):
Radiomedix, Inc.

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

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: AlphaMedix Phase 2

Detailed Description:
In this open-label, multicenter, single-arm Phase 2 study, adult subjects with histologically confirmed NETs and positive somatostatin analog imaging, with no prior PRRT (PRRT naive) will be enrolled to receive 212Pb-DOTAMTATE 67.6 μCi/kg dose per cycle

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open Label Study to Evaluate the Safety and Effectiveness of 212Pb-DOTAMTATE in PRRT Naive Subjects With Somatostatin Receptor Expressing Neuroendocrine Tumors
Actual Study Start Date : December 21, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Octreotide

Arm Intervention/treatment
Experimental: Pb212-DOTAMTATE
investigational radiotherapeutic drug targeting somatostatin receptor-positive neuroendocrine tumors
Drug: AlphaMedix
212Pb-DOTAMTATE is a radiolabeled derivative of octreotide targeting somatostatin positive neuroendocrine tumors
Other Name: Pb212-octreotide analog

Primary Outcome Measures :
  1. 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 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.

  2. Number of patients with treatment-related adverse events as assessed by CTCAE v.4.0 [ Time Frame: 24 months after last dose administration ]

Secondary Outcome Measures :
  1. Measurement of the Median Progression free survival (mPFS) [ Time Frame: 24 months after last dose administration ]
    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.

  2. Measurement of Overall Survival (OS) [ Time Frame: 24 months after last dose administration ]
    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.

  3. Measurement of Time to Tumor Progression (TTP) [ Time Frame: 24 months after last dose administration ]
    This measurement will determine the time from start of treatment with 212Pb- DOTAMTATE until disease progression.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female ≥18 years old with unresectable or metastatic histologically confirmed NET
  • 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 must have received and progressed following somatostatin analog administration.
  • 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 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;

    1. Target lesions must be positive (greater than grade 2 uptake Krenning Score) or must have an SUV of more than the normal liver background.
    2. 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. In any case, osteoblastic bone lesions are not measurable.
  • 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:

    1. White blood cell (WBC) ≥2,500/ mm3;
    2. Absolute neutrophil count (ANC) ≥1000/mm3;
    3. Platelets ≥100,000/mm3;
    4. Hemoglobin (HgB) ≥9.0 g/dL;
    5. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤3 X upper limit of normal (ULN);
    6. Total Bilirubin: ≤2 X ULN;
    7. Serum creatinine ≤1.7 mg/dL;
    8. 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

Exclusion Criteria:

  • Prior whole-body radiotherapy or PRRT using 177Lu/90Y/111In-DOTATATE/ DOTATOC or TAT.
  • 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, AA infusion, or 212Pb-DOTAMTATE;
  • Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 1 day) prior to administration of study drug;
  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05153772

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Contact: Ebrahim S Delpassand, MD 7134999733
Contact: Izabela Tworowska 8328682812

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United States, Texas
Excel Diagnostics and Nuclear Oncology Center Recruiting
Houston, Texas, United States, 77042
Contact: Susan S Cork    713-341-3203   
Principal Investigator: Rodolfo Nunez, MD         
Sub-Investigator: Rouzbeh Esfandiari, MD         
Sponsors and Collaborators
Radiomedix, Inc.
Orano Med LLC
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Responsible Party: Radiomedix, Inc. Identifier: NCT05153772    
Other Study ID Numbers: 135150
First Posted: December 10, 2021    Key Record Dates
Last Update Posted: January 10, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radiomedix, Inc.:
neuroendocrine tumors
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents