L19IL2/L19TNF in patients with cutaneous squamous cell carcinoma

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, Safety

The primary objective of the study is to evaluate the activity of intratumoral
L19IL2/L19TNF in patients locally advanced cSCC progressed on or intolerant
to systemic treatment.

Conditions and MedDRA coding

Cutaneous Squamous Cell Carcinoma

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients must have histologically documented, locally advanced cSCC. Patients must have at least one injectable and measurable cutaneous or subcutaneous lesion. Patients must have locally advanced cSCC that has progressed on or cannot tolerate ICI treatment (adjuvant or first line) as assessed by a local multidisciplinary tumor board. Patients with nodal, regional or in transit injectable cSCC 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.
2. Male or female patients, age 18 - 100 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.
3. Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening.
4. Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception
5. Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion criteria 9

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 basal cell carcinoma of the skin (surgically removed at least 4 weeks prior to study entry), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix, early-stage asymptomatic CLL and not under active treatment (Rai 0, Binet A) will be eligible for the study. • Radiation therapy on the tumor sites in the 4 weeks prior to study drug administration. • Current topical or systemic chemotherapy, immunotherapy. • Presence of visceral metastasis.
2. 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, hepatitis B virus (HBV), or hepatitis C virus (HCV). For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
3. 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).
4. Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.
5. 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
6. Known arterial aneurysms.
7. INR > 3.
8. 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 prior the first dose of study drug. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma/COPD is not considered an exclusion criterion.
9. 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 study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Best Overall Response Rate (BORR) as defined by the RECIST 1.1. criteria according to an Independent Central Review (ICR).

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 · 13 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 21 files

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

Application history

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