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    DRUG:

    Fibromun (onfekafusp alfa)

    i
    Other names: L19-TNF, L19TNF, L19TNFalpha, L19 TNF fusion protein
    Company:
    Philogen, Sun Pharma
    Drug class:
    TNFα inhibitor
    Related drugs:
    4ms
    IMAGLIO: A Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma (clinicaltrials.gov)
    P2, N=52, Not yet recruiting, Philogen S.p.A.
    New P2 trial
    |
    temozolomide • Fibromun (onfekafusp alfa)
    10ms
    FLASH: Efficacy and Safety of L19TNF in Previously Treated Patients with Advanced Stage or Metastatic Soft-tissue Sarcoma (clinicaltrials.gov)
    P2, N=98, Active, not recruiting, Philogen S.p.A. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    dacarbazine • Fibromun (onfekafusp alfa)
    11ms
    GLIOSTELLA: A Study with L19TNF in Combination with Lomustine in Patients with Glioblastoma At Progression or Recurrence (clinicaltrials.gov)
    P2, N=90, Recruiting, Philogen S.p.A. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    lomustine • Fibromun (onfekafusp alfa)
    over1year
    FLASH: Efficacy and Safety of L19TNF in Previously Treated Patients With Advanced Stage or Metastatic Soft-tissue Sarcoma (clinicaltrials.gov)
    P2, N=98, Recruiting, Philogen S.p.A. | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial primary completion date • Metastases
    |
    dacarbazine • Fibromun (onfekafusp alfa)
    over1year
    GLIOASTRA: Safety and Efficacy of Different Administration Sequences of L19TNF With Lomustine in Glioblastoma at First Progression (clinicaltrials.gov)
    P1, N=0, Withdrawn, Philogen S.p.A. | N=24 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    lomustine • Fibromun (onfekafusp alfa)
    over1year
    FIBROSARC: A Study Comparing the Efficacy of L19TNF+Doxorubicin vs Doxorubicin Alone as First-line Therapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma (clinicaltrials.gov)
    P3, N=102, Recruiting, Philogen S.p.A. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    doxorubicin hydrochloride • Fibromun (onfekafusp alfa)
    over1year
    DOXO75: Dose Finding Study of L19TNF and Doxorubicin in Patients With STS (clinicaltrials.gov)
    P1, N=2, Active, not recruiting, Philogen S.p.A. | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    doxorubicin hydrochloride • Fibromun (onfekafusp alfa)
    over1year
    GLIOSTAR: A Study to Evaluate Safety and Efficacy of L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression (clinicaltrials.gov)
    P1/2, N=142, Recruiting, Philogen S.p.A. | Trial primary completion date: Nov 2023 --> Mar 2025
    Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    IDH wild-type
    |
    lomustine • Fibromun (onfekafusp alfa)
    over1year
    GLIOSTELLA: A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Philogen S.p.A.
    New P2 trial • Combination therapy
    |
    lomustine • Fibromun (onfekafusp alfa)
    almost2years
    GLIOSTAR: A Study to Evaluate Safety and Efficacy of L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression (clinicaltrials.gov)
    P1/2, N=142, Recruiting, Philogen S.p.A.
    Trial completion date • Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    IDH wild-type
    |
    lomustine • Fibromun (onfekafusp alfa)
    2years
    Phase I study results of the antibody-cytokine fusion protein L19TNF in combination with lomustine for patients with recurrent glioblastoma reveal promising safety and durable tumor responses (SNO 2023)
    Subsequent re-challenge with L19TNF and lomustine again led to a partial response. These encouraging results justify further investigations within the phase II part of the clinical trial that is recruiting patients in four countries.
    Clinical • P1 data • Combination therapy
    |
    TNFA (Tumor Necrosis Factor-Alpha) • CRP (C-reactive protein)
    |
    lomustine • Fibromun (onfekafusp alfa)
    2years
    DOXO75: Dose Finding Study of L19TNF and Doxorubicin in Patients With STS (clinicaltrials.gov)
    P1, N=2, Active, not recruiting, Philogen S.p.A. | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    doxorubicin hydrochloride • Fibromun (onfekafusp alfa)