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)

NCT06217666 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: URGIP24061
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Adenocarcinoma

Keywords

Pancreatic Adenocarcinoma; Pancreatic Cancer; PCX12; IL-12

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Rate of radiographic response

  2 months

• Change in biomarkers of innate and adaptive immunity

  baseline and 4 weeks

Study Arms (1)

PCX-12

EXPERIMENTAL

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

Interventions

PCX-12 DRUG

treatment combining radiation therapy with PCX12

PCX-12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haoming (Carl) Qiu: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Haoming Qiu

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haoming Qiu

CONTACT

585-275-5863; WCICTOResearch@URMC.Rochester.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor - Department of Radiation Oncology (SMD)

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 22, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)