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)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
研究概览
简要总结
The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: PCX-12 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
时间窗: 3 years
The Primary objective of the safety lead in component is to report acute, attributable, gastrointestinal toxicity
Maximum tolerable dose [Safety and Tolerability]
时间窗: 3 years
Maximum tolerable dose is defined by less than or equal to 30% dose limiting toxicity (DLT) event rate within a given dose
次要结局
- Rate of radiographic response(2 months)
- Change in biomarkers of innate and adaptive immunity(baseline and 4 weeks)
研究者
Haoming (Carl) Qiu
Associate Professor - Department of Radiation Oncology (SMD)
University of Rochester