A Phase 1, Prospective, Standard Dose Escalation Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC)

Trial ID: NCT06217666

Interventional - Phase 1 - Not yet recruiting

The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable.

Conditions

Patient with pathologically proven diagnosis of adenocarcinoma of the pancreas
After chemotherapy, tumor is determined to be either locally advanced or unresectable by hepatobiliary surgeon; or tumor is considered potentially resectable but subject does not proceed with surgical resection for any reason
Have completed first line chemotherapy without progression or non-regional metastases
Tumor is radiographically evident on CT scan after chemotherapy
Tumor is anatomically amenable to SBRT, e.g. does not directly invade the stomach or bowel
Tumor is amenable to intra-tumor injection under endoscopic ultrasound guidance
ECOG performance status 0-2
Patients with childbearing potential must demonstrate a negative urine or serum pregnancy test
Male or female subjects, aged at least 18 years; Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the three months after study completion; Adequate contraception is defined as resulting in a failure rate of less than 1% per year
Patient must be able to understand and willingly sign study specific informed consent prior to study entry
Anticipated life expectancy ≥ 12 weeks
Patients aged at least 18 years of age

Progression of disease or metastatic disease after first line systemic therapy
Prior radiation treatment or surgical resection of any pancreatic malignancy
Inability to tolerate SBRT, Endoscopic ultrasound or IL-12 Injection procedure
Lack of radiographically evident disease after first line chemotherapy
Severe, active comorbidity that shortens the patient's life expectancy to less than 12 weeks
History of past malignancy
Patient who is pregnant and/or breastfeeding
Inability to comply with other required protocol procedures including required biopsies

Haoming (Carl) Qiu