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L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)

NCT07227350 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-03-10

No results posted yet for this study

Summary

Open label, randomized 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 evaluate the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF, the secondary objectives of this study are to evaluate efficacy, safety and pharmacokinetics of immunocytokines. A minimum of 60 patients and a maximum of 180 evaluable patients will be randomized in a 1:1:1 ratio to one of the three different treatment arms of the study and will receive intralesional injections of: (i) Monotherapy 13 Mio IU (\~2.17 mg) L19IL2; or (ii) Monotherapy 0.4 mg L19TNF; or (iii) Combination of 13 Mio IU L19IL2 + 0.4 mg L19TNF, once weekly for 4 consecutive weeks. Newly injectable lesions occurring within the 4-week treatment period of the initial target lesion will also receive multiple intratumoral administrations of immunocytokines once weekly for up to 4 weeks. Patients will be followed for a maximum of 156 weeks after beginning of treatment

Conditions

  • Locally Advanced Basal Cell Carcinoma

Interventions

DRUG

L19IL2

Intratumoral injections

DRUG

L19TNF

Intratumoral injections

DRUG

L19IL2/L19TNF

Intratumoral injections

Sponsors & Collaborators

  • Philogen S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2031-02-28
Completion
2031-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07227350 on ClinicalTrials.gov