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AlphaMedix

Phase 2

Neuroendocrine Tumors | Small molecule | Oncology |Sanofi|Last Updated: Apr 15, 2026

Success Probability

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment69

FDA Designations

No designations recorded

Clinical trial landscape

AlphaMedix · 1 trial · 1 indication

Phase 2 1
NCT05153772Targeted Alpha-emitter Therapy of PRRT Naïve and Previous PRRT Neuroendocrine Tumor PatientsNeuroendocrine Tumors
ACTIVE NOT_RECRUITING69 Analytics
PHASE2ACTIVE NOT_RECRUITING
Targeted Alpha-emitter Therapy of PRRT Naïve and Previous PRRT Neuroendocrine Tumor Patients
Neuroendocrine TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Measurement of the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
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.

Number of patients with treatment-related adverse events as assessed by CTCAE v.4.0
24 months after last dose administration

To assess the safety and tolerability of 212Pb-DOTAMTATE

Secondary Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pb212-DOTAMTATEEXPERIMENTALinvestigational radiotherapeutic drug targeting somatostatin receptor-positive neuroendocrine tumors in PRRT naive patients (Cohort 1) and previous PRRT patients (Cohort 2)

Interventions

NameTypeDescription
AlphaMedixDRUG212Pb-DOTAMTATE is a radiolabeled derivative of octreotide targeting somatostatin positive neuroendocrine tumors
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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...

Countries:United States
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Frequently asked questions about AlphaMedix

What is AlphaMedix used for in Neuroendocrine Tumors?

AlphaMedix is an investigational small molecule being studied for the treatment of Neuroendocrine Tumors. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in patients with Neuroendocrine Tumors, including those who have not received prior peptide receptor radionuclide therapy (PRRT) and those who have previously undergone PRRT.

What does AlphaMedix target?

AlphaMedix is a targeted alpha-emitter therapy, meaning it delivers alpha radiation to cancer cells. While the specific molecular target is not disclosed, the therapy is designed to treat Neuroendocrine Tumors by exploiting their biological characteristics. It is being studied in a Phase 2 trial to assess its safety and efficacy in this patient population.

Who makes AlphaMedix?

AlphaMedix is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical research on AlphaMedix as an investigational therapy for Neuroendocrine Tumors, with the drug currently in Phase 2 development.

What phase is AlphaMedix in?

AlphaMedix is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 trial is actively recruiting participants, though enrollment is complete, and the study is no longer recruiting new patients.

What clinical trials is AlphaMedix in?

AlphaMedix is being evaluated in a single Phase 2 clinical trial registered as NCT05153772, titled 'Targeted Alpha-emitter Therapy of PRRT Naïve and Previous PRRT Neuroendocrine Tumor Patients.' The trial is active but not recruiting, with an enrollment of 69 participants in the United States. It is an open-label, uncontrolled study.

Is AlphaMedix the same as any other drug?

AlphaMedix is not known to have alternative names. It is a distinct investigational small molecule developed by Sanofi for the treatment of Neuroendocrine Tumors. No other names or aliases for this drug have been disclosed in the available clinical trial information.