L19IL2 or L19TNF or L19IL2/TNF in patients with basal cell carcinoma (BCC)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Philogen S.p.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

27 Apr 2026 → ongoing

Decision date (initial)

2026-02-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF.

Conditions and MedDRA coding

locally advanced basal cell carcinoma patients

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 15

1. 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.
2. Patients with at least one injectable and measurable cutaneous or subcutaneous lesion.
3. Patients must not have received prior checkpoint inhibitors systemic treatment
4. Patients may have received prior surgery and/or radiation therapy.
5. Patients must have a histologically confirmed disease
6. BCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely
7. Anticipated substantial morbidity and/or deformity from surgery
8. Medical conditions predisposing to poor surgical outcome
9. Other conditions considered to be medically contraindicating must be discussed with the Medical Monitor before enrolling the patient.
10. ECOG Performance Status/WHO Performance Status ≤ 1.
11. Hemoglobin > 10.0 g/dL.
12. Platelets > 100 x 109/L.
13. ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).
14. 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
15. Patients must have previously received radiotherapy for their locally advanced BCC, unless it was contraindicated or not appropriate

Exclusion criteria 14

1. 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
2. Radiation therapy on the tumor sites in the 4 weeks prior to study drug administration.
3. Current topical or systemic chemotherapy, targeted therapy immunotherapy
4. Patients with node positive BCC who are candidates for checkpoint inhibitor therapy
5. Presence of visceral metastasis.
6. 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
7. 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
8. Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.
9. 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.
10. Known arterial aneurysms.
11. INR > 3.
12. Uncontrolled hypertension.
13. Known uncontrolled coagulopathy or bleeding disorder.
14. Known hepatic cirrhosis or severe pre-existing hepatic impairment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Philogen S.p.A.

Sponsor organisation

Philogen S.p.A.

Address

Piazza La Lizza 7

City

Siena

Postcode

53100

Country

Italy

Scientific contact point

Organisation

Philogen S.p.A.

Contact name

Lisa Nadal

Public contact point

Organisation

Philogen S.p.A.

Contact name

Concetta Aulicino

Third parties 1

Locations

4 EU/EEA countries · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications