Lung Cancer
Conditions
Keywords
aglatimagene besadenovec, CAN-2409, immunotherapy, GMCI, AdV-tk
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.
Detailed description
The purpose of this open-label, dose escalation clinical trial is to investigate the safety of CAN-2409 (aglatimagene besadenovec) plus prodrug prior to surgery in patients with NSCLC. CAN-2409 is a viral immunotherapy approach which utilizes intratumoral administration to selectively induce tumor cell death and elicit both an innate and an adaptive systemic anti-tumor immune response against the injected tumor and uninjected metastases. Local delivery enables these effects while aiming to minimize systemic toxicity. Standard of care surgical resection will be performed about 3 weeks after the CAN-2409 injection. Chemotherapy and/or radiation may begin 6-8 weeks after resection surgery. Choice of chemotherapy depends on the treating oncologist. CAN-2409 (aglatimagene besadenovec) was previously known as AdV-tk, and the combination of CAN-2409 plus prodrug was previously known as GMCI.
Interventions
BIOLOGICALCAN-2409 + valacyclovir
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.
Sponsors
University of Pennsylvania
Candel Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
Exclusion criteria
* 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. * Prior bone marrow transplants (including stem cells) except autologous stem cell transplant without immunosuppression is NOT considered an exclusion. * Known sensitivity or allergic reactions to valacyclovir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment emergent adverse events | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | 5 years |
| Overall survival (OS) | 5 years |
Countries
United States
Outcome results
None listed