CAN-2409 + Chemoradiation/SBRT for Pancreatic Cancer
(PaTK02 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for individuals with a specific form of pancreatic cancer that might be removable with surgery. The researchers aim to determine if adding a new drug, CAN-2409 (also known as aglatimagene besadenovec), to standard treatments like chemotherapy and radiation is safe and effective. The trial compares this new approach to usual care to assess its efficacy. Individuals who have undergone treatment for pancreatic cancer with a specific type of chemotherapy and are now considering surgery might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that CAN-2409, when combined with a medication like valacyclovir or acyclovir, has been tested in other studies for safety. These studies found no unexpected safety issues, indicating that the treatment is generally well-tolerated. Specifically, one study found that after 36 months, no new side effects appeared, which reassures potential participants.
The treatment has also shown promising effectiveness, often aligning with safety data. Additionally, CAN-2409 has received FDA Orphan Drug Designation for pancreatic cancer, indicating potential benefits and safety in treating serious conditions.
Overall, existing data suggests that people have tolerated CAN-2409 with a prodrug well in past studies.12345Why are researchers excited about this trial's treatments?
Researchers are excited about CAN-2409 combined with chemoradiation or stereotactic body radiation therapy (SBRT) for pancreatic cancer because it uses a unique mechanism to enhance the body's ability to fight cancer. Unlike traditional treatments that directly target cancer cells, CAN-2409 involves a gene therapy approach where a virus helps deliver a specific gene into the cancer cells, making them more susceptible to destruction when a prodrug like valacyclovir or acyclovir is administered. This approach has the potential to improve the effectiveness of existing treatments by making the cancer cells more vulnerable to radiation and chemotherapy, potentially leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for pancreatic cancer?
In this trial, participants in the test arm will receive CAN-2409 combined with a prodrug like valacyclovir, alongside neoadjuvant chemoradiation or SBRT, followed by surgery. Studies have shown that CAN-2409, when paired with a drug like valacyclovir, can significantly benefit patients with pancreatic cancer. Specifically, previous studies reported a 30% increase in the time patients lived without cancer recurrence. Additionally, research found that 71.4% of patients treated with CAN-2409 were still alive after two years, compared to only 16.7% in a group that did not receive the treatment. This treatment strengthens the body's immune system to fight cancer cells more effectively. These findings suggest that CAN-2409 could be a powerful tool against pancreatic cancer.12367
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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