glembatumumab vedotin (CDX-011) / Celldex 
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 11 Diseases   1 Trial   1 Trial   105 News 


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  • ||||||||||  glembatumumab vedotin (CDX-011) / Celldex
    Targeting GPNMB in Renal Tumors in Tuberous Sclerosis Complex and Translocation Renal Cell Carcinoma (Live; Virtual) -  Jun 16, 2023 - Abstract #KCRS2023KCRS_33;    
    GPNMB is a transcriptional target of the MiT/TFE family and a potentially oncogenic cell-surface protein which is highly amenable to therapeutic targeting using fully human and clinically tested anti-GPNMB antibodies such as glembatumumab (CR011)...Innovation: We will be the first to test the hypothesis that GPNMB is an oncogenic driver and biomarker of tumorigenesis in the context of high MiT/TFE activity in tRCC or TSC1/2-deficient renal tumors. Moreover, we will be the first to develop and examine the efficacy of an alpha particle-based radiopharmaceutical therapy (aRPT) for tRCC and tumors with TSC1/2 loss, representing an entirely new and targeted treatment paradigm for these molecular RCC subtypes.
  • ||||||||||  Review, Journal, BRCA Biomarker:  From seaside to bedside: Current evidence and future perspectives in the treatment of breast cancer using marine compounds. (Pubmed Central) -  Sep 29, 2022   
    A deeper knowledge of the mechanism of action and of the potential predictive factors for response to marine-derived drugs is important for their rational and effective use, alone or in combination. In this narrative review, we discuss the role of marine-derived drugs for the treatment of BC, although most of them are not approved, and the opportunities that could arise from the potential treasure trove of the sea for novel BC therapeutics.
  • ||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
    Review, Journal:  Actively Targeted Nanomedicines in Breast Cancer: From Pre-Clinal Investigation to Clinic. (Pubmed Central) -  Mar 11, 2022   
    In this work, all these active targeted nanomedicines are discussed, analyzing their advantages and disadvantages over conventional chemotherapy as well as the challenges involved in their lab to clinical translation. In addition, examples of formulations developed and evaluated at the preclinical level are also discussed.
  • ||||||||||  glembatumumab vedotin (CDX-011) / Celldex
    Journal:  BARONESS CHARLOTTA CASTELLI GLEMBAY - WAS SHE HYPERSEXUAL? (Pubmed Central) -  Mar 4, 2022   
    In addition, examples of formulations developed and evaluated at the preclinical level are also discussed. No abstract available
  • ||||||||||  glembatumumab vedotin (CDX-011) / Celldex, BGT226 / Novartis
    [VIRTUAL] High-throughput small molecule screens reveal therapeutic opportunities against TFE3-fusion renal cell carcinoma (Channel 1) -  Sep 7, 2020 - Abstract #AACRNCIEORTC2020AACR_NCI_EORTC_125;    
    PI3K/mTOR pathway inhibitors (NVP-BGT226), transcription inhibitors (Mithramycin), and combinations among each other and with the antibody-drug conjugate CDX-011, show promising preclinical efficacy against TFE3-fusion RCC. This preclinical study provides an unbiased foundation to identify potential therapeutic approaches against TFE3-fusion RCC patients.
  • ||||||||||  glembatumumab vedotin (CDX-011) / Celldex
    P2 data, Journal:  A Phase II Study of Glembatumumab Vedotin for Metastatic Uveal Melanoma. (Pubmed Central) -  Aug 24, 2020   
    The disease control rate was 57% despite a low objective response rate. Exploratory immune correlation studies are underway to provide insight into target saturation, combination strategies, and antigen release.
  • ||||||||||  tebentafusp (IMCgp100) / Immunocore, glembatumumab vedotin (CDX-011) / Celldex
    Biomarker, Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO Biomarker:  Immunotherapy for uveal melanoma - Current knowledge and perspectives. (Pubmed Central) -  May 15, 2020   
    This may include immunotherapy with IMCgp100, glembatumumab vedotin and the infusion of autologous TILs, targeted therapy with selective MEK inhibitors, epigenetic therapy and nanotherapy. A better insight to the molecular and genetic profile of uveal melanoma will facilitate detection of new prognostic biomarkers and thus enable a better modification of the existing immunotherapy methods and development of new forms of treatment specifically designed for uveal melanoma patients.
  • ||||||||||  tebentafusp (IMCgp100) / Immunocore, glembatumumab vedotin (CDX-011) / Celldex
    CNS metastases in uveal melanoma () -  Nov 21, 2019 - Abstract #SMR2019SMR_284;    
    The median overall survival from UM diagnosis, from metastatic UM diagnosis, and from CNSM diagnosis in this cohort was 93 months, 29 months, and 7.5 months, respectively. To our knowledge this is the largest cohort of UM patients with CNSM described.
  • ||||||||||  sacituzumab govitecan (IMMU-132) / Immunomedics, glembatumumab vedotin (CDX-011) / Celldex, ladiratuzumab vedotin (SGN-LIV1A) / Seattle Genetics
    Journal, BRCA Biomarker:  Antibody-drug conjugates in triple negative breast cancer. (Pubmed Central) -  Apr 3, 2019   
    One emerging treatment modality includes antibody-drug conjugates which are highly selective monoclonal antibodies conjugated to cytotoxic agents, designed to deliver cytotoxic drugs to antigen-expressing tumor cells. This review will highlight three antibody-drug conjugates currently being evaluated in TNBC (CDX-011, SGN-LIV1a, IMMU-132), including one that has been given Breakthrough Therapy designation from the US FDA.
  • ||||||||||  glembatumumab vedotin (CDX-011) / Celldex
    Trial termination, Combination therapy, Monotherapy, PD(L)-1 Biomarker, IO biomarker, Metastases:  A Study of Glembatumumab Vedotin as Monotherapy or in Combination With Immunotherapies in Patients With Advanced Melanoma (clinicaltrials.gov) -  Oct 18, 2018   
    P2,  N=132, Terminated, 
    This review will highlight three antibody-drug conjugates currently being evaluated in TNBC (CDX-011, SGN-LIV1a, IMMU-132), including one that has been given Breakthrough Therapy designation from the US FDA. Active, not recruiting --> Terminated; Development of glembatumumab vedotin was discontinued
  • ||||||||||  glembatumumab vedotin (CDX-011) / Celldex
    Trial completion, Trial primary completion date, Metastases:  Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma (clinicaltrials.gov) -  Oct 17, 2018   
    P2,  N=37, Completed, 
    Active, not recruiting --> Terminated; Development of glembatumumab vedotin was discontinued Active, not recruiting --> Completed | Trial primary completion date: Oct 2017 --> Jul 2018
  • ||||||||||  glembatumumab vedotin (CDX-011) / Celldex
    Trial completion date, Trial termination, Metastases:  PrECOG 0504: Study of Glembatumumab Vedotin in gpNMB-Expressing, Advanced or Metastatic SCC of the Lung (clinicaltrials.gov) -  Oct 1, 2018   
    P1/2,  N=13, Terminated, 
    Active, not recruiting --> Completed | Trial primary completion date: Oct 2017 --> Jul 2018 Trial completion date: May 2019 --> Sep 2018 | Active, not recruiting --> Terminated; Company discontinued further development of study drug for this indication
  • ||||||||||  glembatumumab vedotin (CDX-011) / Celldex
    Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, PD(L)-1 Biomarker, IO biomarker, Metastases:  A Study of Glembatumumab Vedotin as Monotherapy or in Combination With Immunotherapies in Patients With Advanced Melanoma (clinicaltrials.gov) -  Sep 7, 2018   
    P2,  N=132, Active, not recruiting, 
    Trial completion date: May 2019 --> Sep 2018 | Active, not recruiting --> Terminated; Company discontinued further development of study drug for this indication Trial completion date: Oct 2020 --> Dec 2018 | Trial primary completion date: Oct 2018 --> Jun 2018
  • ||||||||||  glembatumumab vedotin (CDX-011) / Celldex, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
    Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date, PD(L)-1 Biomarker, Surgery, Metastases:  Glembatumumab Vedotin, Nivolumab, and Ipilimumab in Treating Patients With Advanced Metastatic Solid Tumors That Cannot Be Removed by Surgery (clinicaltrials.gov) -  Jul 18, 2018   
    P1/2,  N=0, Withdrawn, 
    Active, not recruiting --> Completed N=103 --> 0 | Trial completion date: Aug 2020 --> Apr 2018 | Not yet recruiting --> Withdrawn | Trial primary completion date: Aug 2020 --> Apr 2018
  • ||||||||||  glembatumumab vedotin (CDX-011) / Celldex
    Trial completion date, Trial primary completion date, Metastases:  PrECOG 0504: Study of Glembatumumab Vedotin in gpNMB-Expressing, Advanced or Metastatic SCC of the Lung (clinicaltrials.gov) -  Jun 26, 2018   
    P1/2,  N=13, Active, not recruiting, 
    N=103 --> 0 | Trial completion date: Aug 2020 --> Apr 2018 | Not yet recruiting --> Withdrawn | Trial primary completion date: Aug 2020 --> Apr 2018 Trial completion date: Aug 2019 --> May 2019 | Trial primary completion date: Apr 2019 --> May 2018
  • ||||||||||  glembatumumab vedotin (CDX-011) / Celldex
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Metastases:  PrECOG 0504: Study of Glembatumumab Vedotin in gpNMB-Expressing, Advanced or Metastatic SCC of the Lung (clinicaltrials.gov) -  Apr 27, 2018   
    P1/2,  N=13, Active, not recruiting, 
    Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=52 --> 13 | Trial completion date: Aug 2020 --> Aug 2019 | Trial primary completion date: Apr 2020 --> Apr 2019
  • ||||||||||  glembatumumab vedotin (CDX-011) / Celldex
    Enrollment change, Trial primary completion date:  AOST1521: Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma (clinicaltrials.gov) -  Feb 7, 2018   
    P2,  N=22, Active, not recruiting, 
    Recruiting --> Active, not recruiting | N=52 --> 13 | Trial completion date: Aug 2020 --> Aug 2019 | Trial primary completion date: Apr 2020 --> Apr 2019 N=38 --> 22 | Trial primary completion date: Feb 2018 --> Jun 2017
  • ||||||||||  glembatumumab vedotin (CDX-011) / Celldex
    Trial primary completion date, Combination therapy, Monotherapy, PD(L)-1 Biomarker, IO biomarker, Metastases:  A Study of Glembatumumab Vedotin as Monotherapy or in Combination With Immunotherapies in Patients With Advanced Melanoma (clinicaltrials.gov) -  Dec 15, 2017   
    P2,  N=130, Recruiting, 
    Overall, these studies demonstrate that [89Zr]DFO-CR011 is a potential companion diagnostic imaging agent for CDX-011 which targets gpNMB, an emerging biomarker for TNBC. Trial primary completion date: Jun 2018 --> Oct 2018