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AdV-tk+ valacyclovir

Phase 1

Malignant Pleural Effusion | Monoclonal antibody | Oncology |Candel Therapeutics, Inc.|Last Updated: Aug 25, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

AdV-tk+ valacyclovir · 1 trial · 5 indications

Phase 1 1
NCT01997190Intrapleural AdV-tk Therapy in Patients With Malignant Pleural EffusionMalignant Pleural Effusion
COMPLETED19 Analytics
PHASE1COMPLETED
Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion
Malignant Pleural EffusionUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment emergent adverse events
8 weeks

Secondary Endpoints

Progression-free survival
5 years
Overall survival
10 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Study ArmEXPERIMENTALAdV-tk + valacyclovir

Interventions

NameTypeDescription
AdV-tk + valacyclovirBIOLOGICALAdV-tk will be administered intrapleural through pleural catheter followed by oral valacyclovir. Valacyclovir will be administered orally at a fixed dose for 14 days after each AdV-tk administration.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients must have MPE (defined as positive pleural fluid cytology). Eligible patients include NSCLC, small cell lung cancer, malignant mesothelioma (MM), breast cancer and ovarian cancer. Diagnosis must be made prior to AdV-tk injection. For patients with MM, histologic proof...

Countries:United States
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Frequently asked questions about AdV-tk+ valacyclovir

What is AdV-tk used for?

AdV-tk is an investigational gene therapy being studied for use in oncology, specifically for pancreatic adenocarcinoma, malignant pleural effusion, malignant glioma, and glioma. It has been evaluated in Phase 1 clinical trials for these conditions, including pediatric brain tumors and pancreatic cancer.

Who makes AdV-tk?

AdV-tk is being developed by Candel Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol CADL.

What phase is AdV-tk in?

AdV-tk is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All completed trials for AdV-tk are Phase 1 studies.

What clinical trials is AdV-tk in?

AdV-tk has been studied in several completed Phase 1 trials, including NCT00634231 for pediatric brain tumors, NCT00638612 for pancreatic cancer, NCT01997190 for malignant pleural effusion, and NCT03576612 for high-grade gliomas.

Is AdV-tk the same as GMCI?

AdV-tk is also known as GMCI, which stands for gene-mediated cytotoxic immunotherapy. In clinical trials, it has been referred to as GMCI when combined with other treatments like nivolumab and radiation therapy for gliomas.