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)
Haoming (Carl) Qiu
Summary
The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable.
Description
Single center, open label, escalating dosage of PCX12 with standard of care practice for subjects who are diagnosed with adenocarcinoma of the head of the pancreas. Subjects with undergo standard of care radiation therapy and then start on PCX12 therapy starting at 200 ng/kg of PCX12 escalating to a potential maximum dosage of 800 ng/kg of PCX12 with adjacent tolerability and safety guidelines.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugPCX-12
treatment combining radiation therapy with PCX12
Location
- University of RochesterRochester, New York