BIFIKAFUSP ALFA for Locally advanced basal cell carcinoma

Inclusion criteria

• {"criterion_text":"- 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.\n- Patients with at least one injectable and measurable cutaneous or subcutaneous lesion.\n- Patients must not have received prior checkpoint inhibitors systemic treatment\n- Patients may have received prior surgery and/or radiation therapy.\n- Patients must have a histologically confirmed disease\n- BCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely\n- Anticipated substantial morbidity and/or deformity from surgery\n- Medical conditions predisposing to poor surgical outcome\n- Other conditions considered to be medically contraindicating must be discussed with the Medical Monitor before enrolling the patient.\n- ECOG Performance Status/WHO Performance Status ≤ 1.\n- Hemoglobin > 10.0 g/dL.\n- Platelets > 100 x 109/L.\n- ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).\n- 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\n- Patients must have previously received radiotherapy for their locally advanced BCC, unless it was contraindicated or not appropriate"}

Exclusion criteria

• {"criterion_text":"- 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\n- Radiation therapy on the tumor sites in the 4 weeks prior to study drug administration.\n- Current topical or systemic chemotherapy, targeted therapy immunotherapy\n- Patients with node positive BCC who are candidates for checkpoint inhibitor therapy\n- Presence of visceral metastasis.\n- 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\n- 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\n- Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.\n- 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 L/min/1.73m2.\n- Known arterial aneurysms.\n- INR > 3.\n- Uncontrolled hypertension.\n- Known uncontrolled coagulopathy or bleeding disorder.\n- Known hepatic cirrhosis or severe pre-existing hepatic impairment."}

Primary endpoints

• {"endpoint_text":"- The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF.","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

30-01-2026

Latest Decision Or Authorization Date

16-02-2026

Processing Time Days

17

Number Of Sites

1

Number Of Participants

24

Germany

Earliest CTIS Part Ii Submission Date

29-01-2026

Latest Decision Or Authorization Date

11-02-2026

Processing Time Days

13

Number Of Sites

6

Number Of Participants

26

Greece

Earliest CTIS Part Ii Submission Date

13-11-2025

Latest Decision Or Authorization Date

11-02-2026

Processing Time Days

90

Number Of Sites

1

Number Of Participants

10

Italy

Earliest CTIS Part Ii Submission Date

08-01-2026

Latest Decision Or Authorization Date

10-02-2026

Processing Time Days

33

Number Of Sites

4

Number Of Participants

25

Primary sponsor

Full Name

Philogen S.p.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Contract research organisations

Name

Pharmassist Ltd.

Responsibilities

sponsor duties (sponsorDuties id 914996, code 1); contact s.chatziioannou@pharmassist-cro.com; phone 00302106560700

Third parties

• {"country":"Greece","full_name":"Pharmassist Ltd.","duties_or_roles":"sponsorDuties code 1; contact s.chatziioannou@pharmassist-cro.com, phone 00302106560700","organisation_type":"Pharmaceutical company"}