2024-516019-26-00招募中2 期
RR001 in Combination with Chemotherapy for Patients with Locally Advanced Pancreatic Adenocarcinoma: Open-label, Non-randomized Dose Escalation Phase I/IIa Study
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To investigate the safety, feasibility of intratumoral injections of the gene therapy product RR001 administered by US guided injection in combination with standard of care therapy based on GEM/Nab-PTX
研究概览
简要总结
- To determine the safety, feasibility of intra-tumoral injection of the RR001 administered by ultrasound (US) guided injections in combination with standard of care therapy based on GEM/Nab-PTX
- To establish the maximal tolerated dose (MTD) and recommended phase IIb dose (RP2D) of intratumoral injections of RR001 after three dose levels delivery in combination with standard of chemotherapy
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically and/or cytologically confirmed pancreatic ductal adenocarcinoma
- •Adequate hepatic function, with bilirubin < 1.5 x the ULN, and AST and ALT < 2.5 x ULN
- •Adequate kidney function with serum creatinine <2 x the ULN or creatinine clearance >30 mL/min
- •Absolute neutrophil count (ANC) ≥1.0 x 10e9/l, hemoglobin ≥9 g/dl, platelet count ≥ 100 x 10e9/l, prothrombin (INR) <1.5
- •Life expectancy of at least 12 weeks
- •Negative serum pregnancy test for females of childbearing potential within days of starting treatment
- •Willingness and ability to comply with the scheduled visits, treatment plan, imaging procedures, laboratory tests and other study procedures, including lipoaspirate
- •Patients with no evidence of peritoneal or hematogenous metastasis
- •Patients classified as non-resectable LAPC based on imaging (TC and NMR), on multidisciplinary staff evaluation by at least an oncologist, radiologist and a qualified digestive surgeon and accounting for AJCC/UICC TNM and clinical staging
- •Measurable tumor according RECIST criteria v 1.1
- •Low tumor burden with at least one lesion equal/less than 3,5 cm that is suitable for US guided injection (and needle biopsy)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- •Patients must be eligible for standard of care treatment with GEM/Nab-PTX
- •Patient older than 18 years of age
- •Evidence of a personally signed and dated Ethics Committee-approved Informed consent form indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study
排除标准
- •Female patients with childbearing age or pregnancy or breast feeding. Female patients shall agree to use effective contraception or be surgically sterile or postmenopausal
- •Previous of radiotherapy and chemotherapy for PDAC
- •Previous haematopoietic stem cell or organ transplantation
- •Irreversible cardiac arrhythmias requiring permanent medication
- •Heart insufficiency (> grade II, New York Heart Association NYHA criteria)
- •History within the last year of acute or subacute coronary cyndromes including myocardial infarction, unstable or severe stable angina pectoris
- •Uncontrolled hypertension
- •Patient not efficiently treated for jaundice (biliary stent or bypass) if present at time of diagnosis
- •Other malignancies within the past 2 years (not including basal cell carcinoma of the skin, prostate cancer or in situ cervix carcinoma, in situ melanoma)
- •Moderate to large volume ascites
- •Active autoimmune disease
- •Patient with pancreatic cystic tumor or pancreatic pseudocyst
- •Use of any investigational agents within 21 days from the administration of study treatment
- •Patient has had major open surgery within the 3 months prior to the administration of study treatment
- •Uncontrolled intercurrent illness including but not limited to psychiatric illness/social situations that in the opinion of the Investigator would compromise compliance of study requirements or put the patient at unacceptable risk
- •Patient with pancreatic tumor different from adenocarcinoma (endocrine, metastases)
- •Patients with unknown stage or recurrent pancreatic cancer
- •Patients with immunosuppression or susceptibility to viral infection
- •Patients with HIV, hepatitis B, hepatitis C, HTLV-I/II, Treponema Pallidum infections
- •Patients with liver cirrhosis or other documented liver diseases
- •Patient contraindication to gemcitabine +nab-paclitaxel treatments
- •Patients with not approachable US window for intratumoral injection of RR001 as evaluated by US examination of the abdomen
结局指标
主要结局
To investigate the safety, feasibility of intratumoral injections of the gene therapy product RR001 administered by US guided injection in combination with standard of care therapy based on GEM/Nab-PTX
To investigate the safety, feasibility of intratumoral injections of the gene therapy product RR001 administered by US guided injection in combination with standard of care therapy based on GEM/Nab-PTX
To establish the MTD and RP2D of intratumoral injections of RR001 after three dose levels delivery in combination with standard of care therapy
To establish the MTD and RP2D of intratumoral injections of RR001 after three dose levels delivery in combination with standard of care therapy
次要结局
- Quality of life by scoring of quality of life according to the EORTC QLQ-C30 and QLQ-PAN26
- Target tumor response: antitumor activity will be assessed by objective radiologic assessment using RECIST 1.1 criteria
- Response rate: the overall rates for objective response (complete, partial responses, stable disease, progressive disease) will be assessed by objective radiographic assessment using RECIST 1.1 criteria
- Percentage of patients successfully undergoing to surgery and percentage of pathological resection (R0 vs. R1 vs. R2)
- Time to disease progression
- Progression free survival (PFS)
- Overall survival (OS)
- Tumor markers in serum (CEA, CA19.9 if present at the diagnosis)
研究者
Giorgio Mari
Scientific
Eir Biotherapies S.r.l.
研究点 (1)
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