2025-523231-19-00招募中2 期
A Phase 2 study of intratumoral administration of L19IL2/L19TNF in locally advanced Cutaneous Squamous Cell Carcinoma patients progressing on or intolerant to systemic treatment.
Philogen S.p.A.4 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2026年2月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Best Overall Response Rate (BORR) as defined by the RECIST 1.1. criteria according to an Independent Central Review (ICR).
研究概览
简要总结
The primary objective of the study is to evaluate the activity of intratumoral L19IL2/L19TNF in patients locally advanced cSCC progressed on or intolerant to systemic treatment.
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 must have histologically documented, locally advanced cSCC. Patients must have at least one injectable and measurable cutaneous or subcutaneous lesion. Patients must have locally advanced cSCC that has progressed on or cannot tolerate ICI treatment (adjuvant or first line) as assessed by a local multidisciplinary tumor board. Patients with nodal, regional or in transit injectable cSCC lesions. Patients must be willing to provide tissue from a core or excisional biopsy of a tumor lesion at screening and for confirmation of Objective Response or Stable Disease.
- •Male or female patients, age 18 - 100 years. ECOG Performance Status/WHO Performance Status ≤
- •Hemoglobin > 10.0 g/dL. Platelets > 100 x 109/L. ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN). All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Grade ≤ 1 unless otherwise specified.
- •Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening.
- •Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception
- •Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
排除标准
- •Presence of concomitant malignancies, with the exception of any cancer curatively treated more than 3 years prior to study entry and of tumors with a negligible risk for metastasis or death, such as adequately treated basal cell carcinoma of the skin (surgically removed at least 4 weeks prior to study entry), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix, early-stage asymptomatic CLL and not under active treatment (Rai 0, Binet A) will be eligible for the study. • Radiation therapy on the tumor sites in the 4 weeks prior to study drug administration. • Current topical or systemic chemotherapy, immunotherapy. • Presence of visceral metastasis.
- •Presence of active severe bacterial or viral infections or other severe concurrent disease/infection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV). For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
- •History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris,inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).
- •Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.
- •Chronically impaired renal function as indicated by creatinine clearance < 60 mL/min/1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance < 45 mL/min/1.73m2
- •Known arterial aneurysms.
- •Uncontrolled hypertension. • Known uncontrolled coagulopathy or bleeding disorder. • Known hepatic cirrhosis or severe pre-existing hepatic impairment. • Moderate to severe respiratory failure. • Active autoimmune disease that has required systemic treatment in past 2 years. • Patients have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma/COPD is not considered an exclusion criterion.
- •Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies. • Pregnancy or breast-feeding. • Ischemic peripheral vascular disease (Grade IIb-IV). • Severe diabetic retinopathy. • Recovery from major trauma including surgery within 4 weeks prior to enrollment. • Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression. • Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
结局指标
主要结局
Best Overall Response Rate (BORR) as defined by the RECIST 1.1. criteria according to an Independent Central Review (ICR).
Best Overall Response Rate (BORR) as defined by the RECIST 1.1. criteria according to an Independent Central Review (ICR).
次要结局
未报告次要终点
研究者
Lisa Nadal
Scientific
Philogen S.p.A.
研究点 (4)
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