labetuzumab govitecan (IMMU-130) / Gilead 
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 0 Diseases   1 Trial   1 Trial   36 News 
  • ||||||||||  labetuzumab govitecan (IMMU-130) / Gilead
    Clinical Trial,Phase I, Journal:  Multimodal CEA-targeted fluorescence and radioguided cytoreductive surgery for peritoneal metastases of colorectal origin. (Pubmed Central) -  May 21, 2022   
    P1/2
    In this study (ClinicalTrials.gov NCT03699332) we describe the results of a phase I clinical trial evaluating [In]In-DOTA-labetuzumab-IRDye800CW, a dual-labeled anti-carcinoembryonic antigen (anti-CEA) antibody conjugate that enables both preoperative imaging and intraoperative radioguidance and fluorescence imaging...Alteration of clinical strategy based on multimodal imaging occurred in three patients. Thus, multimodal image-guided surgery after administration of this dual-labeled tracer is a promising approach that may aid in decision making before and during cytoreductive surgical procedures.
  • ||||||||||  labetuzumab govitecan (IMMU-130) / Gilead
    Enrollment change, Trial withdrawal, Metastases:  A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer (clinicaltrials.gov) -  Dec 7, 2020   
    P2,  N=0, Withdrawn, 
    Most importantly, the antigen-dependent induction of immune-stimulating cytokines promises a robust immune response that combines the activation of innate and adaptive arms. N=50 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  labetuzumab govitecan (IMMU-130) / Immunomedics
    Journal:  Impact of Different Selectivity between Soluble and Membrane-bound Forms of Carcinoembryonic Antigen (CEA) on the Target-mediated Disposition of Anti-CEA Monoclonal Antibodies. (Pubmed Central) -  May 29, 2020   
    In this study, we compared the effect of sCEA on the pharmacokinetics of 15-1-32 in mice with that of another anti-CEA monoclonal antibody, labetuzumab, showing less selectivity to mCEA than 15-1-32...Although the effect of soluble CEA on the serum concentration of 15-1-32 was very small, the clearance of 15-1-32 in CEA-positive tumor-bearing mice was still rapid, suggesting membrane-bound CEA also contributes to the clearance of anti-CEA antibodies. These results indicated that increasing selectivity to membrane-bound CEA is not enough to improve the pharmacokinetics of anti-CEA antibody.
  • ||||||||||  labetuzumab govitecan (IMMU-130) / Gilead
    Enrollment change, Trial withdrawal, Metastases:  IMMU-130-02: Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer (clinicaltrials.gov) -  May 12, 2020   
    P1/2,  N=0, Withdrawn, 
    These results indicated that increasing selectivity to membrane-bound CEA is not enough to improve the pharmacokinetics of anti-CEA antibody. N=71 --> 0 | Completed --> Withdrawn
  • ||||||||||  labetuzumab govitecan (IMMU-130) / Immunomedics
    [VIRTUAL] Multimodal fluorescence-guided surgery of colorectal peritoneal metastases, a phase I/II clinical trial. (Poster Board 111) -  Feb 27, 2020 - Abstract #ASCO2020ASCO_369;    
    P1/2
    In this phase I/II single arm protein dose escalation study patients with peritoneal metastases of colorectal origin who are scheduled for cytoreductive surgery and HIPEC will receive an intravenous injection of the CEA-targeting tracer 111In-DOTA-labetuzumab-IRDye800CW...The secondary objectives are to assess whether additional malignant lesions can be visualized by fluorescence imaging after cytoreductive surgery, to assess the intensity of fluorescence in malignant and non-malignant tissue, to assess the correlation between localization of the dual-labeled antibody and CEA expression in tumor and healthy tissue and to determine blood concentrations of the dual labelled antibody at several time points in patients. Research Funding: Dutch Cancer Foundation
  • ||||||||||  labetuzumab govitecan (IMMU-130) / Gilead
    Trial completion, Trial completion date, Metastases:  IMMU-130-02: Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer (clinicaltrials.gov) -  Apr 20, 2019   
    P1/2,  N=71, Completed, 
    In this continuing study, we show that CEA‐targeted multimodal imaging in patients with colorectal peritoneal carcinomatosis is feasible and safe in the first patients. Active, not recruiting --> Completed | Trial completion date: Mar 2019 --> Oct 2018
  • ||||||||||  labetuzumab govitecan (IMMU-130) / Gilead
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Metastases:  IMMU-130-02: Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer (clinicaltrials.gov) -  Nov 15, 2018   
    P1/2,  N=71, Active, not recruiting, 
    Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=104 --> 71 | Trial completion date: Dec 2016 --> Mar 2019 | Trial primary completion date: Dec 2016 --> Oct 2018
  • ||||||||||  labetuzumab govitecan (IMMU-130) / Gilead
    Trial primary completion date, Metastases:  IMMU-130-02: Study of Labetuzumab Govitecan in Participants With Metastatic Colorectal Cancer (clinicaltrials.gov) -  Mar 21, 2016   
    P1/2,  N=104, Recruiting, 
    Recruiting --> Active, not recruiting | N=104 --> 71 | Trial completion date: Dec 2016 --> Mar 2019 | Trial primary completion date: Dec 2016 --> Oct 2018 Trial primary completion date: Dec 2015 --> Dec 2016
  • ||||||||||  labetuzumab govitecan (IMMU-130) / Gilead
    Trial completion, Metastases:  Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer (clinicaltrials.gov) -  Feb 22, 2014   
    P1/2,  N=30, Completed, 
    Recruiting --> Active, not recruiting No longer recruiting --> Completed