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CAN-2409+ valacyclovir

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment12

FDA Designations

FAST_TRACKORPHAN_DRUGRMAT

Clinical trial landscape

CAN-2409+ valacyclovir · 1 trial · 1 indication

Phase 1 1
NCT03131037Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung CancerLung Cancer
COMPLETED12 Analytics
PHASE1COMPLETED
Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer
Lung CancerUnlock trial analytics

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 to 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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Competitive Landscape -Lung Cancer 281 trials

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Frequently asked questions about CAN-2409+ valacyclovir

What is CAN-2409 used for?

CAN-2409 is an investigational oncology therapy being studied for malignant glioma and lung cancer. In malignant glioma, it has been evaluated in a Phase 2a study combined with standard radiation therapy for conditions including glioblastoma multiforme, anaplastic astrocytoma, and high grade glioma. It has also been studied in patients with resectable non-small cell lung cancer.

Who is developing CAN-2409?

CAN-2409 is being developed by Candel Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CADL. The company is conducting clinical research on this investigational therapy for oncology indications.

What phase is CAN-2409 in?

CAN-2409 is in Phase 2 clinical development. A Phase 2a study of CAN-2409 with standard radiation therapy for malignant glioma has been completed. An additional Phase 1 study in resectable non-small cell lung cancer has also been completed. The drug is investigational and not yet approved.

What clinical trials is CAN-2409 in?

CAN-2409 has been studied in two completed clinical trials. NCT00589875 was a Phase 2a study of CAN-2409 with standard radiation therapy for malignant glioma, enrolling 52 participants in the United States. NCT03131037 was a Phase 1 study of intratumoral gene mediated cytotoxic immunotherapy in patients with resectable non-small cell lung cancer, enrolling 12 participants.

What FDA designations has CAN-2409 received?

CAN-2409 has received Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy (RMAT) designations from the U.S. Food and Drug Administration. These designations are intended to facilitate development and review of therapies for serious conditions.

Does CAN-2409 target a specific biomarker?

CAN-2409 is not being studied with a biomarker-selected patient population in its clinical trials. The completed trials enrolled patients based on their cancer diagnosis rather than on specific molecular biomarkers.