2025-523229-16-00招募中2 期
A Phase 2 controlled randomized study of the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF intralesional injections for the treatment of locally advanced basal cell carcinoma patients.
Philogen S.p.A.4 个研究点 分布在 1 个国家目标入组 25 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
- 25
- 试验地点
- 4
- 主要终点
- The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF.
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with high risk, locally advanced histologically confirmed (non-metastatic, node negative, single or multifocal), BCC and amenable to intratumoral injection, not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board.
- •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
- •Patients must have previously received radiotherapy for their locally advanced BCC, unless it was contraindicated or not appropriate
- •Patients with at least one injectable and measurable cutaneous or subcutaneous lesion.
- •Patients must not have received prior checkpoint inhibitors systemic treatment
- •Patients may have received prior surgery and/or radiation therapy.
- •Patients must have a histologically confirmed disease
- •BCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely
- •Anticipated substantial morbidity and/or deformity from surgery
- •Medical conditions predisposing to poor surgical outcome
- •Other conditions considered to be medically contraindicating must be discussed with the Medical Monitor before enrolling the patient.
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 squamous-cell carcinoma of the skin
- •Known arterial aneurysms.
- •Uncontrolled hypertension.
- •Known uncontrolled coagulopathy or bleeding disorder.
- •Known hepatic cirrhosis or severe pre-existing hepatic impairment.
- •Radiation therapy on the tumor sites in the 4 weeks prior to study drug administration.
- •Current topical or systemic chemotherapy, targeted therapy immunotherapy
- •Patients with node positive BCC who are candidates for checkpoint inhibitor therapy
- •Presence of visceral metastasis.
- •Presence of active serious infections or other severe conditions requiring treatment, including positive tests for HIV-1/2, HBV, or HCV. For HBV, HBsAg and anti-HBc must be tested; if previously exposed, HBV-DNA must be negative. For HCV, HCV-RNA or antibody testing is required
- •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 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.
结局指标
主要结局
The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF.
The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF.
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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