fresolimumab (GC 1008) / Sanofi 
Welcome,         Profile    Billing    Logout  
 60 Diseases   0 Trials   0 Trials   83 News 


12»
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Pharmacological suppression of cancer associated fibroblast (CAF)-driven tumor fibrosis identified by the PRO-C3 biomarker in NSCLC (Foyer) -  Feb 5, 2026 - Abstract #ELCC2026ELCC_842;    
    CAFs were treated with the ALK5/TGF-?1 receptor kinase inhibitor (ALK5i) or Fresolimumab (antibody targetingTGF-?) to investigate if the PRO-C3 and collagen deposition could be pharmacologically modified by therapeutic intervention.Results PRO-C3 was produced by lung CAFs after activation with TGF-beta but not PDGF-AB, IL-1 and IL-6 (p<0.0001)...These findings support that modulating CAFs can be monitored in vitro and that treating tumor fibrosis in NSCLC may be achived. Here, PRO-C3 may support drug development efforts already from drug discovery through clinical evaluation.
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Journal:  In-silico prediction of TGF-?1 non-synonymous variants and their impact on binding affinity to Fresolimumab. (Pubmed Central) -  Nov 21, 2024   
    Among them, the E35D variant significantly destabilized the TGF-?1 protein structure, resulting in rearrangement in the binding site and affecting the interactions with the Fresolimumab. This study identified four variants that can affect the TGF-?1 protein structure and result in functional consequences such as impaired response to Fresolimumab.Communicated by Ramaswamy H. Sarma.
  • ||||||||||  Bone-targeted anti-TGF (Meeting Room 718 South) -  Aug 5, 2024 - Abstract #ASBMR2024ASBMR_381;    
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Trial completion, Trial completion date:  Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta (clinicaltrials.gov) -  Jul 6, 2022   
    P1,  N=11, Completed, 
    Such colocalized targeting elicits distinct and superior antitumor responses relative to single agent combination therapy. Active, not recruiting --> Completed | Trial completion date: Aug 2023 --> Jul 2022
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Variability of Proteinuria in Nephrotic Syndrome: GC1008 PH2 Trial in FSGS (Mini-Orals Hall) -  May 5, 2022 - Abstract #ERAEDTA2022ERA_EDTA_1031;    
    P2
    These data suggest that labour intensive, cumbersome timed 24-h urine collections should not be performed in clinical trials of nephrotic syndrome patients. Importantly, these data should allow for more precise power and sample size estimates for future interventional clinical trials of nephrotic syndrome.
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Journal:  Targeting transforming growth factor- β (TGF-β) for treatment of osteogenesis imperfecta. (Pubmed Central) -  Apr 5, 2022   
    P1
    Importantly, these data should allow for more precise power and sample size estimates for future interventional clinical trials of nephrotic syndrome. Our data confirm that TGF-β signaling is a driver pathogenic mechanism in OI bone and that anti-TGF-β therapy could be a potential disease-specific therapy with dose-dependent effects on bone mass and turnover.
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Enrollment closed, Enrollment change:  Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta (clinicaltrials.gov) -  Mar 28, 2022   
    P1,  N=11, Active, not recruiting, 
    Our data confirm that TGF-β signaling is a driver pathogenic mechanism in OI bone and that anti-TGF-β therapy could be a potential disease-specific therapy with dose-dependent effects on bone mass and turnover. Recruiting --> Active, not recruiting | N=16 --> 11
  • ||||||||||  Humira (adalimumab) / Eisai, AbbVie
    Review, Journal:  Interventions for focal segmental glomerulosclerosis in adults. (Pubmed Central) -  Mar 8, 2022   
    The final study (109 participants) compared sparsentan, a dual inhibitor of endothelin Type A receptor and of the angiotensin II Type 1 receptor, with irbesartan...Treatment with cyclosporin for at least six months was more likely to achieve complete remission of proteinuria compared with other treatments but there was considerable imprecision due to few studies and small participant numbers. In future studies of existing or new interventions, the investigators must clearly define the populations included in the study to provide appropriate recommendations for patients with primary, genetic or secondary FSGS.
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Trial completion, Trial completion date:  SABR-ATAC: A Trial of TGF-beta Inhibition and Stereotactic Ablative Radiotherapy for Early Stage Non-small Cell Lung Cancer (clinicaltrials.gov) -  Feb 3, 2022   
    P1/2,  N=24, Completed, 
    In future studies of existing or new interventions, the investigators must clearly define the populations included in the study to provide appropriate recommendations for patients with primary, genetic or secondary FSGS. Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Dec 2021
  • ||||||||||  bintrafusp alfa (M7824) / EMD Serono, Merck (MSD), vactosertib (TEW-7197) / National OncoVenture, Medpacto, fresolimumab (GC 1008) / Sanofi
    Review, Journal:  TGFβ-Directed Therapeutics: 2020. (Pubmed Central) -  Nov 17, 2021   
    Two small molecule kinase inhibitors which block the serine-threonine kinase activity of TGFβRI on TGFβRII, a pan-TGFβ neutralizing antibody, a TGFβ trap, a TGFβ antisense agent, an antibody which stabilizes the latent complex of TGFβ and a fusion protein which neutralizes TGFβ and binds PD-L1 are in clinical development. The challenge is how to most effectively incorporate blocking TGFβ activity alone and in combination with other therapeutics to improve treatment outcome.
  • ||||||||||  disitertide (P144) / Avadel, Digna Biotech, fresolimumab (GC 1008) / Sanofi
    Journal:  Discovery of Selective Transforming Growth Factor β Type II Receptor Inhibitors as Antifibrosis Agents. (Pubmed Central) -  Jun 1, 2021   
    In this report, we disclose selective TGF-β type II receptor (TGF-βRII) inhibitors that exhibited high functional selectivity in cell-based assays. The representative compound 29 attenuated collagen type I alpha 1 chain (COL1A1) expression in a mouse fibrosis model, which suggests that selective inhibition of TGF-βRII-dependent signaling could be a new treatment for fibrotic disorders.
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Trial completion date:  Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta (clinicaltrials.gov) -  Apr 22, 2021   
    P1,  N=16, Recruiting, 
    The representative compound 29 attenuated collagen type I alpha 1 chain (COL1A1) expression in a mouse fibrosis model, which suggests that selective inhibition of TGF-βRII-dependent signaling could be a new treatment for fibrotic disorders. Trial completion date: Oct 2022 --> Aug 2023
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Clinical, Journal, PD(L)-1 Biomarker, IO biomarker:  Baseline T cell dysfunction by single cell network profiling in metastatic breast cancer patients. (Pubmed Central) -  Jul 29, 2020   
    P2
    Functional T cell analysis suggests that baseline T cell functionality is hampered in metastatic breast cancer patients, at least in part mediated by the PD-1 signaling pathway. These preliminary data support the rationale for investigating the possible beneficial effects of adding PD-1 blockade to improve responses to TGFβ blockade and radiotherapy.
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Trial completion date, Trial primary completion date:  Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta (clinicaltrials.gov) -  Apr 8, 2020   
    P1,  N=16, Recruiting, 
    Trial completion date: Jan 2020 --> Dec 2021 | Trial primary completion date: Jan 2020 --> Jun 2021 Trial completion date: Aug 2021 --> Oct 2022 | Trial primary completion date: Aug 2021 --> Aug 2022
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Trial completion date, Trial primary completion date:  Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta (clinicaltrials.gov) -  Jan 30, 2020   
    P1,  N=16, Recruiting, 
    Trial completion date: Aug 2021 --> Oct 2022 | Trial primary completion date: Aug 2021 --> Aug 2022 Trial completion date: Aug 2020 --> Aug 2021 | Trial primary completion date: Aug 2020 --> Aug 2021
  • ||||||||||  Orencia (abatacept) / BMS, Humira (adalimumab) / Eisai, AbbVie, Rituxan (rituximab) / Roche, Biogen
    A SUCCESSFUL TREATMENT WITH ABATACEPT IN STEROID RESISTANT FOCAL SEGMENTAL GLOMERULOSCLEROSIS () -  Oct 25, 2019 - Abstract #IPNA2019IPNA_20;    
    Herein we present our experience with abatacept, a cytotoxic Tlymphocyte-associated antigen 4-immunoglobulin fusion protein (CTLA-4-Ig), in a patient diagnosed with primary FSGS and resistant to steroid, cyclosporine A (CsA), Mycofenolat mophetinile (MMF) and rituximab...After administration of abatacept, proteinuria level decreased below 1 gram/day and serum albumin levels increased to 3 mg/dL. This case indicates that abatacept can be at least partially effective in FSGS with resistance to other immunsupressive therapies such as CsA, cyclophosphamide, MMF and rituximab.
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Trial completion:  Fresolimumab and Radiotherapy in Metastatic Breast Cancer (clinicaltrials.gov) -  Mar 5, 2019   
    P2,  N=23, Completed, 
    This case indicates that abatacept can be at least partially effective in FSGS with resistance to other immunsupressive therapies such as CsA, cyclophosphamide, MMF and rituximab. Active, not recruiting --> Completed
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Trial completion date, Trial primary completion date:  Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta (clinicaltrials.gov) -  Jan 22, 2019   
    P1,  N=16, Recruiting, 
    Suspended --> Recruiting Trial completion date: Aug 2019 --> Aug 2020 | Trial primary completion date: Aug 2018 --> Aug 2020
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Trial completion date:  Fresolimumab and Radiotherapy in Metastatic Breast Cancer (clinicaltrials.gov) -  Mar 16, 2018   
    P2,  N=23, Active, not recruiting, 
    Recruiting --> Suspended Trial completion date: Mar 2016 --> Jun 2019
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Trial initiation date:  Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta (clinicaltrials.gov) -  Sep 18, 2017   
    P1,  N=16, Recruiting, 
    However, fresolimumab was well tolerated and is appropriate for continued evaluation in larger studies with adequate power. Initiation date: Jul 2017 --> Nov 2017
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Enrollment open, Trial initiation date:  Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta (clinicaltrials.gov) -  Jul 14, 2017   
    P1,  N=16, Recruiting, 
    Initiation date: Jul 2017 --> Nov 2017 Not yet recruiting --> Recruiting | Initiation date: Apr 2017 --> Jul 2017
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Enrollment change:  Anti-TGF Monoclonal Antibody (GC1008) in Relapsed Malignant Pleural Mesothelioma (clinicaltrials.gov) -  Dec 15, 2015   
    P2,  N=14, Completed, 
    Not yet recruiting --> Recruiting | Initiation date: Nov 2015 --> Aug 2016 | Trial primary completion date: May 2019 --> Jan 2020 N=20 --> 14
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Phase classification, Trial primary completion date:  Fresolimumab and Radiotherapy in Metastatic Breast Cancer (clinicaltrials.gov) -  Oct 27, 2015   
    P2,  N=24, Active, not recruiting, 
    N=20 --> 14 Phase classification: P=N/A --> P2 | Trial primary completion date: Sep 2015 --> Jun 2014
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Trial completion:  Study of GC1008 in Patients With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) -  Apr 11, 2015   
    P1,  N=25, Completed, 
    Phase classification: P=N/A --> P2 | Trial primary completion date: Sep 2015 --> Jun 2014 Active, not recruiting --> Completed
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Trial termination:  Anti-TGF-beta Therapy in Patients With Myelofibrosis (clinicaltrials.gov) -  Dec 9, 2014   
    P1,  N=3, Terminated, 
    Active, not recruiting --> Completed Completed --> Terminated; Early termination when the drug was no longer made available by the pharmaceutical company due to unanticipated management and administrative decisions.
  • ||||||||||  fresolimumab (GC 1008) / Sanofi
    Enrollment closed:  Fresolimumab and Radiotherapy in Metastatic Breast Cancer (clinicaltrials.gov) -  Sep 28, 2014   
    P=N/A,  N=28, Active, not recruiting, 
    Completed --> Terminated; Early termination when the drug was no longer made available by the pharmaceutical company due to unanticipated management and administrative decisions. Recruiting --> Active, not recruiting