Clinical trial NCT06217666: 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)
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Pancreatic Adenocarcinoma
Keywords: Pancreatic Adenocarcinoma
Pancreatic Cancer
PCX12
IL-12
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
timeFrame: 3 years
measure: Maximum tolerable dose [Safety and Tolerability]
timeFrame: 3 years
Secondary outcomes:
measure: Rate of radiographic response
timeFrame: 2 months
measure: Change in biomarkers of innate and adaptive immunity
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Haoming Qiu
role: PRINCIPAL_INVESTIGATOR
References: