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GLA-SE

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

GLA-SE · 1 trial · 1 indication

Phase 1 1
NCT02035657A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell CarcinomaMerkel Cell Carcinoma
COMPLETED10 Analytics
PHASE1COMPLETED
A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma
Merkel Cell CarcinomaUnlock trial analytics

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 to 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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Frequently asked questions about GLA-SE

What is GLA-SE used for in Merkel Cell Carcinoma?

GLA-SE is an investigational monoclonal antibody being studied for the treatment of Merkel Cell Carcinoma. It is currently in Phase 1 clinical development, with one completed proof-of-concept trial involving 10 patients in the United States.

What does GLA-SE target?

GLA-SE is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential role in treating Merkel Cell Carcinoma, a type of skin cancer.

Who makes GLA-SE?

GLA-SE is being developed by Design Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DSGN. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Merkel Cell Carcinoma.

What phase is GLA-SE in?

GLA-SE is in Phase 1 clinical development. A proof-of-concept trial (NCT02035657) has been completed, enrolling 10 patients with Merkel Cell Carcinoma. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is GLA-SE in?

GLA-SE has one completed clinical trial, NCT02035657, titled "A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma." This Phase 1 study enrolled 10 adult patients in the United States and was not randomized or blinded.