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GLA-SE

Phase 1

Merkel Cell Carcinoma | Monoclonal antibody | Oncology |Design Therapeutics, Inc.|Last Updated: Jun 13, 2018

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 Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02035657A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell CarcinomaPHASE1 COMPLETED 10Jan 1, 2014Mar 1, 2018Jun 13, 20181 United States
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Study Endpoints
Primary Endpoints
Safety and feasibility
1 year

The number of treatment-related adverse events

Secondary Endpoints
Clinical efficacy and Immunogenicity
1 Year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GLA-SEEXPERIMENTALGlucopyranosyl Lipid A in Stable Emulsion
Interventions
NameTypeDescription
GLA-SEBIOLOGICALGlucopyranosyl Lipid A in Stable Emulsion
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Biopsy-confirmed Merkel cell carcinoma with metastatic or loco-regional disease. * Patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabiliz...

Countries:United States
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