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)

NCT ID: NCT06217666

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-12-01
• Study Completion Date: 2029-12-31

Brief Summary

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

Detailed 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.

Conditions

Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCX-12

PCX-12 is an experimental immunotherapy drug that is injected into the pancreatic cancer one time in attempt to stimulate the patient's immune system to fight the cancer.

Group Type: EXPERIMENTAL

PCX-12

Intervention Type: DRUG

treatment combining radiation therapy with PCX12

Interventions

PCX-12

treatment combining radiation therapy with PCX12

Intervention Type: DRUG

Eligibility Criteria

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 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haoming (Carl) Qiu

OTHER

Sponsor Role: lead

Responsible Party

Haoming (Carl) Qiu

Associate Professor - Department of Radiation Oncology (SMD)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Haoming Qiu

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Central Contacts

Haoming Qiu

Role: CONTACT

WCICTOResearch@URMC.Rochester.edu

585-275-5863

Facility Contacts

Haoming Qiu

Role: primary

Other Identifiers

URGIP24061

Identifier Type: -

Identifier Source: org_study_id