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CAN-2409 + valacyclovir

Phase 1

Lung Cancer | Monoclonal antibody | Oncology |Candel Therapeutics, Inc.|Last Updated: Jul 11, 2025

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 Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03131037Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung CancerPHASE1 COMPLETED 12May 4, 2017Sep 20, 2023Jul 11, 20251 United States
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Study Endpoints
Primary Endpoints
Incidence of treatment emergent adverse events
6 weeks
Secondary Endpoints
Progression free survival (PFS)
5 years
Overall survival (OS)
5 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Study ArmEXPERIMENTALCAN-2409 + valacyclovir
Interventions
NameTypeDescription
CAN-2409 + valacyclovirBIOLOGICALCAN-2409 will be administered intratumorally followed by oral valacyclovir. Valacyclovir will be administered orally at a fixed dose for 14 days after each injection.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Pathologically documented non-small cell carcinoma (cytology or histology) that is accessible via standard-of-care staging procedures: (1) EBUS or (2) surgical approaches (eg mediastinoscopy, mediastinotomy or VATS). * Resectable with negative lymph nodes based on imaging with...

Countries:United States
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