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AlphaMedix

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment69
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05153772Targeted Alpha-emitter Therapy of PRRT Naïve and Previous PRRT Neuroendocrine Tumor PatientsPHASE2 ACTIVE NOT_RECRUITING 69Dec 21, 2021Dec 1, 2030Apr 15, 20264 United States
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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 — 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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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05153772primaryCompletionDate: changed
LOWMay 24, 2026NCT05153772studyFirstPostDate: changed