Phase 2: testing L19IL2 for Locally Advanced Basal Cell Carcinoma
Open label, randomly assigned study in patients with LaBCC not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board. The primary objective of the study is to measure the how well it works of L19IL2 or L19TNF or L19IL2/L19TNF, the secondary objectives of this study are to evaluate how well it works, safety and pharmacokinetics of immunocytokines.
Official registry: https://clinicaltrials.gov/study/NCT07227350 · Philogen S.p.A. · enrollment listed as 180
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are L19IL2, L19TNF, or L19IL2/L19TNF. The registry lists allocation as randomized. Open label, randomly assigned study in patients with LaBCC not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board.
They plan to enroll about 180 people at 18 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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 (LaBCC)
Interventions: L19IL2, L19TNF, L19IL2/L19TNF
Primary outcome (registry wording): Best Overall Response Rate
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Patients with at least one injectable and measurable cutaneous or subcutaneous lesion
- Patients must not have received prior HHIs and checkpoint inhibitors systemic treatment
- Patients may have received prior surgery and/or radiation therapy
- 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 (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation);
- Medical conditions predisposing to poor surgical outcome (e.g., diabetes with history of poor wound healing);
- Other conditions considered to be medically contraindicating must be discussed with the Medical Monitor before enrolling the patient
Who the registry excludes
- Current topical or systemic chemotherapy, targeted therapy immunotherapy
- Patients with node positive BCC who are candidates for checkpoint inhibitor therapy
- 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
- 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
- Known arterial aneurysms
- Uncontrolled hypertension
Public study contact (from the registry)
Lisa Nadal
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
18 listed- H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc. — Tampa, Florida (recruiting)
- Winship Cancer Institute, Emory University — Atlanta, Georgia (recruiting)
- Duke University Medical Center — Durham, North Carolina (recruiting)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio (not_yet_recruiting)
- The Ohio State University Wexner Medical Center Clinical Laboratories — Columbus, Ohio (not_yet_recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas (recruiting)
+ 12 sites outside the US on the same record
FAQ about this NCT record
Is NCT07227350 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07227350?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07227350?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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