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Also known as Pb212-octreotide analog
AlphaMedix · 1 trial · 1 indication
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.
To assess the safety and tolerability of 212Pb-DOTAMTATE
| Arm | Type | Description |
|---|---|---|
| Pb212-DOTAMTATE | EXPERIMENTAL | investigational radiotherapeutic drug targeting somatostatin receptor-positive neuroendocrine tumors in PRRT naive patients (Cohort 1) and previous PRRT patients (Cohort 2) |
| Name | Type | Description |
|---|---|---|
| AlphaMedix | DRUG | 212Pb-DOTAMTATE is a radiolabeled derivative of octreotide targeting somatostatin positive neuroendocrine tumors |
Inclusion Criteria: * 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...
AlphaMedix is an investigational small molecule therapy being developed by Sanofi for the treatment of neuroendocrine tumors, a type of cancer in the oncology therapeutic area. It is currently in Phase 2 clinical development and has not been approved by the FDA.
AlphaMedix is being studied for use in patients with neuroendocrine tumors. The Phase 2 trial enrolls adults aged 18 years and older, including both patients who have not previously received peptide receptor radionuclide therapy and those who have had prior PRRT.
AlphaMedix is being developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the sponsor of the Phase 2 clinical program evaluating AlphaMedix in neuroendocrine tumors.
AlphaMedix is in Phase 2 clinical development. It is an investigational therapy and is not FDA approved. The ongoing Phase 2 study is active but no longer recruiting participants, and no trials of AlphaMedix have been completed.
AlphaMedix is being evaluated in the Phase 2 trial NCT05153772, titled Targeted Alpha-emitter Therapy of PRRT Naive and Previous PRRT Neuroendocrine Tumor Patients. The study is active but not recruiting, has enrolled 69 participants, is uncontrolled, and is being conducted in the United States.
Yes, the AlphaMedix Phase 2 trial NCT05153772 is biomarker selected, meaning enrollment is limited to patients whose tumors meet a defined biomarker criterion. The study enrolls adults 18 years and older of all sexes and does not accept healthy volunteers.