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)

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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Adenocarcinoma
• Intervention / Treatment: Drug: PCX-12

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Haoming Qiu; Phone Number: 585-275-5863; Email: WCICTOResearch@URMC.Rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
      • Contact: Haoming Qiu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient with pathologically proven diagnosis of adenocarcinoma of the pancreas
• Initially staged as locally advanced by National Comprehensive Cancer Network (NCCN) criteria of solid tumor contact with aorta, superior mesenteric artery (SMA) or celiac axis >180 degrees and/or unreconstructable superior mesenteric vein/portal vein (SMV/PV) due to portal involvement or occlusion, tumor contact with most proximal draining jejunal branch into SMV
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: PCX-12; treatment combining radiation therapy with PCX12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])	The Primary objective of the safety lead in component is to report acute, attributable, gastrointestinal toxicity	3 years
Maximum tolerable dose [Safety and Tolerability]	Maximum tolerable dose is defined by less than or equal to 30% dose limiting toxicity (DLT) event rate within a given dose	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of radiographic response	This study will assess radiographic response following SBRT and PCX12 utilizing RECIST 1.1 criteria	2 months
Change in biomarkers of innate and adaptive immunity	A combination of flow/mass cytometry will be employed to assess intratumoral immune cells before and after treatment. Specifically, cells of the adaptive immune system, namely B and T cells (both CD4+ and CD8+), along with innate cells including monocytes, macrophages, neutrophils, and natural killer cells will be investigated and percent of total CD45+ cells along with absolute cell number will be tabulated. Additionally, markers of activation (IFNg, TNF, etc.) along with suppression (PD1, PD-L1, LAG3, etc.) will be included in the panel of analysis.	baseline and 4 weeks

Collaborators and Investigators

• Sponsor: Haoming (Carl) Qiu
• Investigators: Principal Investigator: Haoming Qiu, University of Rochester

Study record dates

Study Major Dates

• Study Start (Estimated): October 31, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Pancreatic Adenocarcinoma; IL-12; PCX12
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: UGIP20052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No