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)

Pancreatic Adenocarcinoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06217666
• Other study ID #: UGIP20052
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 31, 2024
• Est. completion date: January 1, 2028

Study information

• Verified date: January 2024
• Source: University of Rochester
• Contact: Haoming Qiu
• Phone: 585-275-5863
• Email: WCICTOResearch[@]URMC.Rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

Drug:
• PCX-12
treatment combining radiation therapy with PCX12

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Haoming (Carl) Qiu

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Rate of radiographic response	This study will assess radiographic response following SBRT and PCX12 utilizing RECIST 1.1 criteria	2 months
Secondary	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