← Pipeline|ALE-9377

ALE-9377

Approved
Source: Trial-derived·Trials: 4
Modality
mAb
MOA
DLL3 ADC
Target
CD19
Pathway
Lipid Met
GAHCCBCC
Development Pipeline
Preclinical
~Nov 2009
~Feb 2011
Phase 1
~May 2011
~Aug 2012
Phase 2
~Nov 2012
~Feb 2014
Phase 3
~May 2014
~Aug 2015
NDA/BLA
~Nov 2015
~Feb 2017
Approved
May 2017
Mar 2031
ApprovedCurrent
NCT06992518
2,333 pts·BCC
2017-05TBD·Not yet recruiting
NCT08196568
554 pts·HCC
2025-062027-07·Terminated
NCT08345133
2,287 pts·HCC
2024-102031-03·Not yet recruiting
+1 more trial
5,279 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2025-12-243mo agoPh3 Readout· BCC
2027-07-091.3y awayPh3 Readout· HCC
2031-03-014.9y awayPh3 Readout· HCC
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
Approved
Not yet…
Approved
Recruit…
Approved
Not yet…
Approved
Termina…
Catalysts
Ph3 Readout
2025-12-24 · 3mo ago
BCC
Ph3 Readout
2027-07-09 · 1.3y away
HCC
Ph3 Readout
2031-03-01 · 4.9y away
HCC
RecruitingTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
NCTPhaseIndicationStatusNEP
NCT06992518ApprovedBCCNot yet recr...2333CfB
NCT08196568ApprovedHCCTerminated554PASI75
NCT08345133ApprovedHCCNot yet recr...2287UPDRS
NCT03662120ApprovedBCCRecruiting1056MWD
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-8662PfizerNDA/BLACD19GLP-1ag
NVS-4076NovartisPreclinicalTROP-2DLL3 ADC
NVS-6974NovartisPreclinicalCD19HPK1i
VoxarasimodMerck & CoPhase 1/2CD19AuroraAi
RimamavacamtenMerck & CoPhase 1PI3KαDLL3 ADC
AMG-9654AmgenPhase 2GPRC5DDLL3 ADC
TirarelsinTG TherapeuticsNDA/BLACD19IL-17i
TixatapinarofArvinasPhase 1/2CDK2DLL3 ADC
VYG-2926VoyagerNDA/BLACD19PI3Ki
SDG-1247SchrodingerPhase 1CD19RAS(ON)i