A new phase II clinical trial is evaluating the safety and effectiveness of 212Pb-DOTAMTATE in patients who have somatostatin receptor-expressing neuroendocrine tumors but who have not received peptide receptor radionuclide therapy, or PPRT.
Radiomedix, Inc. and Orano Med LLC initiated the study, called ALPHAMEDIX02, which is being led by Houston-based radiologist Rodolfo Nunez, MD. The ALPHAMEDIX02 clinical trial will measure the response rate of treatment with the alpha-emitter therapy with 212Pb-DOTAMTATE (also called AlphaMedix™) as well as measure progression-free survival, overall survival, and the length of time to tumor progression.
Approximately 34 adult patients are expected to take part in the multicenter study, with treatment consisting of up to four cycles of 212Pb-DOTAMTATE.
Inclusion and Exclusion Criteria
- Among the criteria for participating in the ALPHAMEDIX02 clinical trial, patients must have:
- Unresectable or metastatic histologically confirmed NET
- Documented disease progression with the last year
- Received and progressed following somatostatin analog administration
- Confirmed presence of somatostatin receptors on all lesions
- Eastern Cooperative Oncology Group (ECOG) status 0-2
- Sufficient bone marrow capacity and organ function
NET patients with the following are not eligible to take part in the trial:
- Prior whole-body radiotherapy or PRRT using 177Lu/90Y/111In-DOTATATE/ DOTATOC or targeted alpha-emitter therapy (TAT)
- Prior regional hepatic radionuclide therapy in the last 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)
- Participation in other interventional clinical studies within 30 days of beginning the study
Other inclusion and exclusion criteria apply for the ALPHAMEDIX02 trial.
About the Drug
AlphaMedixTM is a radiolabeled SSTR-targeting therapeutic investigational drug for treating NETs. The product consists of SSTR-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha-emitting particles. 212Pb is a rare alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT).
Next Steps
Additional information on the study can be found at clinicaltrials.gov. Interested participants should talk to their treatment team about eligibility and determine if the study is aligned with their treatment goals.