domvanalimab (AB154) / Arcus Biosci, Gilead 
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  • ||||||||||  domvanalimab (AB154) / Arcus Biosci, Gilead
    Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases:  A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov) -  Oct 18, 2022   
    P1,  N=75, Active, not recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Oct 2022 --> Feb 2023 | Trial primary completion date: Oct 2022 --> Feb 2023
  • ||||||||||  Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, sotigalimab (PYX-107) / Pyxis Oncology
    New P1/2 trial, Metastases:  Switch Maintenance in Pancreatic (clinicaltrials.gov) -  Jun 15, 2022   
    P1/2,  N=46, Not yet recruiting, 
  • ||||||||||  domvanalimab (AB154) / Arcus Biosci, Gilead
    Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases:  A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov) -  Apr 11, 2022   
    P1,  N=75, Active, not recruiting, 
    Trial completion date: Jun 2022 --> Feb 2023 | Trial primary completion date: Mar 2022 --> Nov 2022 Recruiting --> Active, not recruiting | Trial completion date: May 2022 --> Oct 2022 | Trial primary completion date: May 2022 --> Oct 2022
  • ||||||||||  AB308 / Arcus Biosci, Gilead, Otsuka
    Anti-TIGIT antibodies promote immune activation relevant to targeting stem-like and tumor-specific T cells in combination with anti-PD-1 (Exhibit Hall; P950) -  Apr 8, 2022 - Abstract #IMMUNOLOGY2022IMMUNOLOGY_1910;    
    In mice, while combining Fc-silent or Fc-enabled anti-mouse TIGIT antibody with anti-PD-1 resulted in greater tumor growth inhibition than with anti-PD-1 alone, the activity of Fc-enabled anti-TIGIT was associated with intratumoral Treg depletion. These data provide a rationale for combination with immune-activating agents and support ongoing clinical evaluation of AB154 and AB308 with biomarker strategies focused on understanding the role of Fc functionality.
  • ||||||||||  Trodelvy (sacituzumab govitecan-hziy) / Gilead
    Trial completion date, Trial primary completion date, Metastases:  TROPHY-U-01: Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (clinicaltrials.gov) -  Apr 6, 2022   
    P2,  N=321, Recruiting, 
    These data provide a rationale for combination with immune-activating agents and support ongoing clinical evaluation of AB154 and AB308 with biomarker strategies focused on understanding the role of Fc functionality. Trial completion date: Oct 2024 --> Jun 2025 | Trial primary completion date: Oct 2022 --> Jun 2023
  • ||||||||||  domvanalimab (AB154) / Arcus Biosci, Gilead
    Trial primary completion date, Combination therapy, Monotherapy, Metastases:  A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov) -  Feb 21, 2022   
    P1,  N=74, Recruiting, 
    The predicted TIGIT receptor occupancy within the tumor may be useful for future dose selection or optimization in clinical trials. Trial primary completion date: Jan 2022 --> May 2022
  • ||||||||||  zimberelimab (AB122) / Arcus Biosci, Otsuka, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
    [VIRTUAL] ARC - 10: Phase 3 Study of Zimberelimab ± Domvanalimab vs Standard Chemotherapy in Front - Line, PD - L1 - High, Metastatic NSCLC (ePoster Hall) -  Aug 19, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_1307;    
    P3
    Arm A patients may crossover to Arm B upon documented PD; however, no crossover is allowed from Arm B to Arm C. For Arm A vs Arm B, the primary endpoint is overall survival (OS) and for Arm B vs Arm C, the co-primary endpoints are investigator-assessed PFS and OS; additional endpoints include quality of life assessments and safety. Study recruitment is planned in Asia, Latin America, Africa, and Eastern Europe.
  • ||||||||||  domvanalimab (AB154) / Arcus Biosci, Gilead
    Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases:  A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov) -  Aug 18, 2021   
    P1,  N=74, Recruiting, 
    Study recruitment is planned in Asia, Latin America, Africa, and Eastern Europe. Trial completion date: Nov 2021 --> May 2022 | Trial primary completion date: Jul 2021 --> Jan 2022
  • ||||||||||  Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
    Enrollment open, Combination therapy:  AB154 Combined With AB122 for Recurrent Glioblastoma (clinicaltrials.gov) -  May 2, 2021   
    P1,  N=46, Recruiting, 
    Trial completion date: Aug 2023 --> Oct 2024 | Trial primary completion date: Jun 2023 --> Oct 2022 Not yet recruiting --> Recruiting
  • ||||||||||  Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
    New P1 trial, Combination therapy:  AB154 Combined With AB122 for Recurrent Glioblastoma (clinicaltrials.gov) -  Dec 7, 2020   
    P1,  N=46, Not yet recruiting, 
  • ||||||||||  domvanalimab (AB154) / Arcus Biosci, Gilead
    Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases:  A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov) -  Jun 25, 2020   
    P1,  N=66, Recruiting, 
    Clinical trial identification: NCT04262856. Trial completion date: Dec 2020 --> Nov 2021 | Trial primary completion date: Jul 2020 --> Jul 2021
  • ||||||||||  Combination of anti-TIGIT and anti-PD-1 antibodies enhance antitumor response in a PD-1/TIGIT double HuGEMM™ model engrafted with mouse syngeneic tumors (Virtual Meeting II: E-Posters) -  May 16, 2020 - Abstract #AACRII2020AACR-II_817;    
    TIGIT on CD8+ T cells can inhibit adjacent CD226 co-stimulatory signaling by binding to PVR at a higher affinity or disrupting the homodimerization of CD226.Therefore, various therapeutic monoclonal antibodies against TIGIT have been developed and are now undergoing clinical testing, for example, tiragolumab (Phase II), BMS-986207 (Phase II), AB-154 (Phase I), MK-7684 (Phase I), etc. However, we are still lacking suitable preclinical models for the efficacy assessment and PK/PD evaluation of human TIGIT antibodies...We also used Balb/c Background PD-1/TIGIT dKI HuGEMM mice to test the antitumor effects of tiragolumab monotherapy and its combination with the anti-PD1 antibody Keytruda®, where CT26.WT syngeneic tumors were treated... Our TIGIT KI HuGEMM and PD-1/TIGIT dKI HuGEMM provide powerful preclinical models to assess the efficacy of human TIGIT antibodies and their combination with human anti-PD-1 or other immune modulators.
  • ||||||||||  Baize’an (tislelizumab) / BeiGene, BMS, AB154 / Arcus Biosci, BGB-A1217 / BeiGene
    Profiling exhausted T cells using Vectra® Polaris™multiplex immunofluorescence assay in HNSCC (Virtual Meeting II: E-Posters) -  May 16, 2020 - Abstract #AACRII2020AACR-II_3750;    
    Currently AB154, a fully humanized immunoglobulin G1 monoclonal antibody targeting human TIGIT is in phase I clinical trials in HNSCC patients and BGB-A1217, an anti-TIGIT monoclonal antibody in combination with anti-PD-1 monoclonal antibody Tislelizumab is in a Phase 1/1b clinical trial in patients with advanced solid tumors. The Vectra Polaris imaging reported in this study identifies T cell composition in the tumor microenvironment of patients facing high mortality.
  • ||||||||||  domvanalimab (AB154) / Arcus Biosci, Gilead
    Enrollment change, Combination therapy, Monotherapy, Metastases:  A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov) -  Apr 16, 2019   
    P1,  N=242, Recruiting, 
    The data presented here provide: 1) rationale for clinical development of a non-depleting a-TIGIT blocking antibody (AB154), 2) evidence of AB154-related immune activation in subjects with advanced solid tumors, 3) evidence supporting AB154 as a rational combination partner with a-PD-1 (AB122). N=42 --> 242