A Phase 2 Open Label Study to Evaluate the Safety and Effectiveness of 212Pb-DOTAMTATE in PRRT Naïve Subjects with Somatostatin Receptor Expressing Neuroendocrine Tumors
This is a phase 2 study of 212Pb-DOTAMTATE enrolling adult patients with positive somatostatin positive neuroendocrine tumors with no prior history of peptide receptor radionuclide therapy (PRRT naive).
The primary objectives of the study are:
To evaluate the efficacy of the Recommended Phase 2 Dose (RP2D) of
212Pb-DOTAMTATE through overall response rate (ORR) complete plus partial
responses per RECIST 1.1: and
To assess the safety and tolerability of 212Pb-DOTAMTATE used for targeted alpha
emitter therapy of peptide receptor radionuclide therapy (PRRT); and
The secondary objectives of the study are:
To determine median Progression free survival (mPFS);
To determine the Overall Survival (OS);
To determine the Time to Tumor Progression (TTP); and
To evaluate the health-related quality of life (HRQL), relative to baseline.
Male or female 18 years of age or older 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;
Patients 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 in protocol.
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
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