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

Part of paid clinical trials in Tampa, Florida.

Sponsor
Philogen S.p.A.
Study ID
NCT07227350
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Basal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • L19IL2 — DRUG
    Intratumoral injections
  • L19TNF — DRUG
    Intratumoral injections
  • L19IL2/L19TNF — DRUG
    Intratumoral injections

Study Details

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

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Feb 28, 2031
Completion
Feb 28, 2031

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: L19IL2
    Patient will receive intralesional injections of monotherapy 13 Mio IU (\~2.17 mg) L19IL2. Frequency and duration are identical for all arms.
  • Experimental: L19IL2/L19TNF
    Patient will receive intralesional injections of Combination of 13 Mio IU L19IL2 + 0.4 mg L19TNF. Frequency and duration are identical for all arms.
  • Experimental: L19TNF
    Patient will receive intralesional injections of monotherapy 0.4 mg L19TNF. Frequency and duration are identical for all arms.

Primary Outcome Measure

Best Overall Response Rate [ Time Frame: from enrollment to week 16 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.TampaFlorida33612
Jonathan S Zager, MD (PRINCIPAL_INVESTIGATOR)
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322
Michael C. Lowe, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Michael R Migden, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By research site
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.· Tampa, FLWinship Cancer Institute, Emory University· Atlanta, GAThe University of Texas MD Anderson Cancer Center· Houston, TX

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