CAN-2409 + Chemoradiation/SBRT for Pancreatic Cancer
(PaTK02 Trial)
Trial Summary
Do I need to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on systemic corticosteroids, immunomodulators, or immunosuppressive drugs.
What data supports the effectiveness of the treatment CAN-2409 + Chemoradiation/SBRT for Pancreatic Cancer?
Research shows that Stereotactic Body Radiation Therapy (SBRT) can deliver high doses of radiation to pancreatic tumors while sparing surrounding tissues, potentially improving tumor control and patient outcomes. Studies indicate that using SBRT in combination with chemotherapy may lead to better survival rates and higher chances of successful tumor removal compared to chemotherapy alone.12345
Is the combination of CAN-2409 and SBRT safe for humans?
How is the treatment CAN-2409 + Chemoradiation/SBRT for pancreatic cancer different from other treatments?
The treatment combines CAN-2409 with chemoradiation and stereotactic body radiation therapy (SBRT), which is a novel approach that delivers high doses of radiation precisely to the tumor in a shorter time, minimizing damage to surrounding tissues and allowing for better integration with chemotherapy. This method may improve surgical outcomes and survival rates compared to traditional radiation therapies.1291011
What is the purpose of this trial?
The purpose of this study is to characterize the safety, preliminary efficacy, and immune biologic activity of CAN-2409 + prodrug (valacyclovir or acyclovir) in subjects with borderline resectable pancreatic cancer who are being treated with neoadjuvant chemoradiation (CR) or stereotactic body radiation therapy (SBRT). The Standard of Care (SOC) Control arm will be used as a benchmark for informal comparisons of efficacy, safety, and biomarkers.
Eligibility Criteria
Adults over 18 with borderline resectable pancreatic cancer, who've had FOLFIRINOX chemotherapy for at least 4 months and are healthy enough for major surgery. They should have no distant metastasis or lymph node involvement outside the planned surgery area, and their tumor must be accessible for injection. Key health metrics like liver function, kidney clearance, blood cell counts need to be within specific ranges.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Therapy
Participants receive at least 4 months (8 cycles) of a FOLFIRINOX based induction therapy
Treatment
Participants receive three courses of CAN-2409 + prodrug, with the first course starting prior to CR or SBRT, the second course concurrent with CR or just following completion of SBRT, and the third at time of resection
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are followed for disease-free survival and overall survival
Treatment Details
Interventions
- Aglatimagene besadenovec
- Chemoradiation
- GMCI (aglatimagene besadenovec + valacyclovir)
- Stereotactic body radiation therapy
Chemoradiation is already approved in China for the following indications:
- Classical Hodgkin’s lymphoma (cHL)
- Locally advanced or metastatic urothelial carcinoma (UC)
- Locally advanced or metastatic non-small cell lung cancer (NSCLC)
- Advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors
- Locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)
- Recurrent or metastatic nasopharyngeal cancer (NPC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Candel Therapeutics, Inc.
Lead Sponsor
Mayo Clinic
Collaborator
Ohio State University
Collaborator