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L19IL2 or L19TNF or L19IL2/TNF in patients with basal cell carcinoma (BCC)
EU CTIS ID: 2025-523229-16-00
What this study is testing
The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 ≤ 1.
- 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
You likely can't join if
- 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.
- INR > 3.
- Uncontrolled hypertension.
- Known uncontrolled coagulopathy or bleeding disorder.
- Known hepatic cirrhosis or severe pre-existing hepatic impairment.
See the full eligibility criteria
- 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 ≤ 1.
- 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.
- 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.
- INR > 3.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.