CAN-2409 + Chemoradiation/SBRT for Pancreatic Cancer

(PaTK02 Trial)

Recruiting at 7 trial locations

Overseen By Andrea Manzanera, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Candel Therapeutics, Inc.

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

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

My tumor can be reached for treatment and might be removable after specific chemotherapy.

My cancer has not spread to distant areas or lymph nodes outside the surgery area.

My cancer involves major veins near my intestines but surgery is possible.

Exclusion Criteria

I do not have any current cancer except for skin cancer.

Known sensitivity or allergic reactions to acyclovir or valacyclovir

Known to be HIV+

Treatment Details

Interventions

• Aglatimagene besadenovec (Virus Therapy)
• Chemoradiation (Radiation)
• GMCI (aglatimagene besadenovec + valacyclovir) (Virus Therapy)
• Stereotactic body radiation therapy (Radiation)

Trial Overview The trial is testing CAN-2409 plus a prodrug (valacyclovir or acyclovir) in patients undergoing neoadjuvant chemoradiation (CR) or stereotactic body radiation therapy (SBRT), followed by surgery. The goal is to assess safety, effectiveness, and immune response compared to standard care.

Participant Groups

Group I: Test Arm Experimental Treatment 4 Interventions

CAN-2409 + prodrug (valacylovir or acyclovir) in combination with neoadjuvant chemoradiation or SBRT + Surgery

Group II: Control Arm Active Control 3 Interventions

Neoadjuvant chemoradiation or SBRT + Surgery

Chemoradiation is already approved in China for the following indications:

Approved in China as Baizean for:

• 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)

Who Is Running the Clinical Trial?

Candel Therapeutics, Inc.

Lead Sponsor

Trials

12

Recruited

1,300+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+