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Fibromun

DRUG12 trials

Sponsors

Philogen S.p.A.

Conditions

Basal Cell Carcinoma (BCC) or cutaneous Squamous Cell Carcinoma (cSCC) amenable to intratumoral injectionCutaneous Squamous Cell CarcinomaGlioblastomaMalignant melanoma of the skin in patients with locally advanced and fully resectable melanoma with/without prior therapy and presence of injectable cutaneous and/or subcutaneous or nodal lesionsPatients with diagnosis of unresectable clinical stage III or IV metastatic melanomaPatients with high-riskPatients with locally advanced Basal Cell Carcinoma (LaBCC) amenable to intratumoral injectionPhase II

Phase 1

A study to evaluate the safety and efficacy of the tumor-targeting human antibody-cytokine fusion protein L19TNF plus standard temozolomide chemoradiotherapy in patients with newly diagnosed glioblastoma.
Not yet recruitingCTIS2024-516357-46-00
Philogen S.p.A.Glioblastoma
Target: 70Updated: 2025-03-14

Phase 2

A randomized study to investigate the efficacy and safety of the tumor-targeting human antibody-cytokine fusion protein L19TNF in previously treated patients with advanced stage or metastatic soft-tissue sarcoma
Active, not recruitingCTIS2024-512704-20-00
Philogen S.p.A.Unresectable and/or metastatic soft-tissue sarcoma after failure of at least two prior systemic therapy regimens.
Start: 2020-06-22Target: 98Updated: 2025-10-20
A Phase II study of intratumoral administration of L19IL2/L19TNF in non-melanoma skin cancer patients with presence of injectable lesions.
CompletedCTIS2024-518530-92-00
Philogen S.p.A.Basal Cell Carcinoma (BCC) or cutaneous Squamous Cell Carcinoma (cSCC) amenable to intratumoral injection, locally advanced (non-metastatic, node negative +3
Start: 2024-12-09End: 2025-10-16Target: 78Updated: 2025-06-24
A Phase II study of L19IL2/L19TNF in patients with skin cancers amenable to intralesional treatment.
Not yet recruitingCTIS2024-518531-10-00
Philogen S.p.A.and in a curative or neoadjuvant or palliative intention, including: • Basal cell carcinoma (BCC) • Cutaneous squamous cell carcinoma (cSCC) • Merkel cell carcinoma (MCC) • Keratoacanthoma (KA) • Malignant adnexal tumors of the skin (MATS) • Tumors from cutaneous T-cell lymphoma (CTCL) • Kaposi’s sarcoma (KS), multicentric +3
Target: 26Updated: 2025-04-22
A dose optimization study for L19TNF in combination with lomustine in patients with glioblastoma at progression or recurrence
WithdrawnCTIS2024-515609-25-00
Philogen S.p.A.Glioblastoma
Target: 20Updated: 2024-12-09
A phase 2, three-arm, randomized study of the efficacy of intratumorally administered L19IL2 or L19TNF or L19IL2/L19TNF, all in combination with systemic anti-PD1 pembrolizumab, in stage III and IV unresectable melanoma patients with resistance to or progressing upon anti-PD1 checkpoint inhibitors and with presence of injectable metastases
Not yet recruitingCTIS2024-519326-20-00
Philogen S.p.A.Patients with diagnosis of unresectable clinical stage III or IV metastatic melanoma, subcutaneous or nodal lesions and resistant to or progressing upon anti-PD1 immunotherapy, with presence of injectable cutaneous
Target: 65Updated: 2026-01-15
A Phase 2 study of intratumoral administration of L19IL2/L19TNF in locally advanced Cutaneous Squamous Cell Carcinoma patients progressing on or intolerant to systemic treatment.
Not yet recruitingCTIS2025-523231-19-00
Philogen S.p.A.Cutaneous Squamous Cell Carcinoma
Target: 43Updated: 2026-02-11
A Phase 2 controlled randomized study of the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF intralesional injections for the treatment of locally advanced basal cell carcinoma patients.
Not yet recruitingCTIS2025-523229-16-00
Philogen S.p.A.locally advanced basal cell carcinoma patients
Target: 61Updated: 2026-02-11
A Phase 2 study of intratumoral administration of L19IL2/L19TNF in locally advanced Basal Cell Carcinoma patients progressed on or intolerant to systemic treatment.
Not yet recruitingCTIS2025-523230-77-00
Philogen S.p.A.Patients with locally advanced Basal Cell Carcinoma (LaBCC) amenable to intratumoral injection, who have progressed or intolerant to systemic treatment.
Target: 42Updated: 2026-02-11

Phase 3

An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C Melanoma Patients
RecruitingCTIS2023-507119-36-00
Philogen S.p.A.Malignant melanoma of the skin in patients with locally advanced and fully resectable melanoma with/without prior therapy and presence of injectable cutaneous and/or subcutaneous or nodal lesions
Start: 2022-05-09Target: 40Updated: 2025-08-13
A Phase III study comparing the efficacy of the combination of doxorubicin and the tumor-targeting human antibody-cytokine fusion protein L19TNF to doxorubicin alone as first-line therapy in patients with advanced or metastatic soft tissue sarcoma
Active, not recruitingCTIS2024-512789-32-00
Philogen S.p.A.Unresectable or metastatic soft tissue sarcoma
Start: 2017-10-09Target: 118Updated: 2025-01-11
A pivotal Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment followed by surgery versus surgery alone in clinical stage III B/C melanoma patients
Active, not recruitingCTIS2024-515749-40-00
Philogen S.p.A.Malignant melanoma of the skin in patients with locally advanced and fully resectable melanoma with/without prior therapy and presence of injectable cutaneous and/or subcutaneous or nodal lesions
Start: 2016-02-25Target: 256Updated: 2026-01-21