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New treatment option for Locally Advanced Basal Cell Carcinoma
Official title L19IL2/TNF in Patients With Basal Cell Carcinoma
ClinicalTrials.gov ID: NCT07227870
What this study is testing
What is L19IL2/L19TNF?
L19IL2/L19TNF is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for locally advanced basal cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Open-label, single-arm, multicentre study in patients with locally advanced BCC amenable to intratumoral injection, who have progressed on or are intolerant to systemic therapy as determined by a local multidisciplinary tumor board. The primary objective of the study is to evaluate the activity of intratumoral L19IL2/L19TNF, while the secondary objective is to assess the safety and efficacy.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically documented, locally advanced BCC.
- Patients must have at least one injectable and measurable cutaneous or subcutaneous lesion.
- Patients must have locally advanced BCC that has progressed on or cannot tolerate HHIs and anti-PD1 treatments assessed by a local multidisciplinary...
- Patients with nodal, regional or in transit injectable BCC 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...
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...
- Current topical or systemic chemotherapy, immunotherapy.
- Presence of visceral metastasis.
- Chronically impaired renal function as indicated by creatinine clearance \< 60 mL/min/1.73m2 or for patients older than 65 years without albuminuria...
- Presence of active severe bacterial or viral infections or other severe concurrent disease/infection requiring therapy, including positive tests for...
- History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris...
See the full eligibility criteria
- Patients must have histologically documented, locally advanced BCC.
- Patients must have at least one injectable and measurable cutaneous or subcutaneous lesion.
- Patients must have locally advanced BCC that has progressed on or cannot tolerate HHIs and anti-PD1 treatments assessed by a local multidisciplinary tumor board.
- Patients with nodal, regional or in transit injectable BCC 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.
- Prior radiotherapy to the target lesions must be completed at least 4 weeks prior to first study drug administration, with all acute RT-related toxicities resolved to ≤ Grade 1
- Male or female patients, who are capable of giving consent, age ≥ 18 years.
- ECOG Performance Status/WHO Performance Status ≤ 2.
- 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. WOCBP must be using, from screening to three months following the last study drug administration, highly effective...
- Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug...
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- 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...
- Current topical or systemic chemotherapy, immunotherapy.
- Presence of visceral metastasis.
- 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.
- 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...
- 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...
- Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.
- Known arterial aneurysms.
- INR \> 3.
- 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...
- 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...
- Patients who have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster...
- Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
- Augsburg, Germany
- Berlin, Germany
- Essen, Germany
- Halle, Germany
- Heidelberg, Germany
- Kiel, Germany
- Tübingen, Germany
- Athens, Greece
- Naples, Italy
- Roma, Italy
- Rozzano, Italy
- Siena, Italy
- Barcelona, Spain
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 study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Atlanta, Georgia, United States; New York, New York, United States; Columbus, Ohio, United States; Houston, Texas, United States; Augsburg, Germany and 12 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.