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delolimogene mupadenorepvec

Phase 1

Malignant Melanoma | Gene therapy | Oncology |Precision BioSciences, Inc.|Last Updated: Sep 19, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

delolimogene mupadenorepvec · 1 trial · 1 indication

Phase 1 1
NCT04123470A Phase I/II Trial Investigating LOAd703 in Combination With Atezolizumab in Malignant MelanomaMalignant Melanoma
COMPLETED24 Analytics
PHASE1COMPLETED
A Phase I/II Trial Investigating LOAd703 in Combination With Atezolizumab in Malignant Melanoma
Malignant MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Tolerability Evaluated by NCI CTCAE v5.0
Up to 57 weeks post treatment initiation

The AE reporting period begins upon receiving the first LOAd703 and/or atezolizumab treatment and continues until final visit at week 57

Secondary Endpoints

Overall Response Rate
Up to 57 weeks post treatment initiation
Overall Survival
From treatment initiation until last patient last visit, assessed up till 36 months
Antibodies Against LOAd703
Up to 57 weeks post treatment initiation
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TreatmentEXPERIMENTALDelolimogene mupadenorepvec plus atezolizumab

Interventions

NameTypeDescription
delolimogene mupadenorepvecGENETICLOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL
atezolizumabBIOLOGICALAtezolizumab is an anti-PD-L1 antibody
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Pathological confirmation of melanoma. 2. A life expectancy of at least 3 months as per the investigator 3. Valid for Swedish patients: Patients has locally advanced melanoma or metastatic melanoma, but not eligible for complete resection of melanoma Valid for US patients: Pa...

Countries:United StatesSweden
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Frequently asked questions about delolimogene mupadenorepvec

What is delolimogene mupadenorepvec used for?

Delolimogene mupadenorepvec is an investigational gene therapy being studied for the treatment of malignant melanoma, a type of skin cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing delolimogene mupadenorepvec?

Delolimogene mupadenorepvec is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol DTIL. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy.

What phase is delolimogene mupadenorepvec in?

Delolimogene mupadenorepvec is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The drug is being evaluated in early-stage clinical trials to assess its safety and potential efficacy.

What clinical trials is delolimogene mupadenorepvec in?

Delolimogene mupadenorepvec has been studied in one clinical trial, identified as NCT04123470. This was a Phase I/II trial investigating the drug in combination with atezolizumab in patients with malignant melanoma. The trial has been completed and enrolled 24 participants.

Is delolimogene mupadenorepvec the same as LOAd703?

Yes, delolimogene mupadenorepvec is also known as LOAd703. The clinical trial NCT04123470, which investigated the drug in malignant melanoma, used the name LOAd703 in its title. Both names refer to the same investigational gene therapy.