Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer

NCT03131037 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: LuTK01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I dose escalation study of CAN-2409 plus prodrug in patients with non-small cell lung cancer (NSCLC). The primary clinical objective of the study is to evaluate the safety of CAN-2409 plus prodrug when combined with standard surgery for NSCLC. The primary scientific objective is to determine the immunologic changes induced by CAN-2409 plus prodrug.

Conditions

Lung Cancer

Keywords

aglatimagene besadenovec; CAN-2409; immunotherapy; GMCI; AdV-tk

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse events

  6 weeks

Secondary Outcomes (2)

• Progression free survival (PFS)

  5 years

• Overall survival (OS)

  5 years

Study Arms (1)

Study Arm

EXPERIMENTAL

CAN-2409 + valacyclovir

Biological: CAN-2409 + valacyclovir

Interventions

CAN-2409 + valacyclovir BIOLOGICAL

CAN-2409 will be administered intratumorally followed by oral valacyclovir. Valacyclovir will be administered orally at a fixed dose for 14 days after each injection.

Study Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 histologic confirmation at time of the staging procedure prior to AdV-tk injection
• The tumor must be 4cm or greater in diameter based on imaging
• ECOG Performance status of 0 or 1.
• Granulocyte count (ANC) ≥ 1,000/mm3
• Peripheral lymphocyte count ≥ 500/mm3
• Hemoglobin ≥ 9 g/dl
• Platelets ≥ 100,000/mm3
• Total bilirubin ≤ 1.5 x upper limit of normal
• SGOT (AST) ≤ 3x upper limit of normal
• Serum creatinine \< 2mg/dl
• Calculated creatinine clearance \> 30ml/min
• Patients must give study specific informed consent prior to enrollment

You may not qualify if:

• Radiotherapy and/or treatment with chemotherapeutic, cytotoxic, or immunologic agents within 4 weeks prior to infusion of the vector.
• Known immunodeficiency such as HIV infection
• Active liver disease, including known cirrhosis or active hepatitis
• Use of systemic corticosteroids (\>10 mg prednisone per day or equivalent) or other systemic immunosuppressive drugs
• Patient is pregnant or breast-feeding. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy. Subjects must use acceptable means of birth control until 30 days after the vector injection.
• Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependence, significant chronic obstructive pulmonary disease (COPD), end-stage liver or renal disease. COPD will be considered significant if disease limits activities of daily living, results in the inability to walk up 1 flight of stair, or requires home oxygen.
• Presence of known untreated brain metastases.
• Known sensitivity or allergic reactions to valacyclovir

Sponsors & Collaborators

• Candel Therapeutics, Inc.: lead
• University of Pennsylvania: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Predina JD, Haas AR, Martinez M, O'Brien S, Moon EK, Woodruff P, Stadanlick J, Corbett C, Frenzel-Sulyok L, Bryski MG, Eruslanov E, Deshpande C, Langer C, Aguilar LK, Guzik BW, Manzanera AG, Aguilar-Cordova E, Singhal S, Albelda SM. Neoadjuvant Gene-Mediated Cytotoxic Immunotherapy for Non-Small-Cell Lung Cancer: Safety and Immunologic Activity. Mol Ther. 2021 Feb 3;29(2):658-670. doi: 10.1016/j.ymthe.2020.11.001. Epub 2020 Nov 5.

  PMID: 33160076 RESULT

Related Links

• Neoadjuvant Gene-Mediated Cytotoxic Immunotherapy for Non-Small-Cell Lung Cancer: Safety and Immunologic Activity

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 27, 2017
• Study Start: May 4, 2017
• Primary Completion: December 1, 2021
• Study Completion: September 20, 2023
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)