acapatamab (AMG 160) / Amgen, BeiGene 
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  • ||||||||||  acapatamab (AMG 160) / Amgen, BeiGene
    Phase classification:  Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) -  Dec 20, 2023   
    P1,  N=3, Terminated, 
    Acapatamab demonstrated pharmacokinetic and pharmacodynamic activity. Phase classification: P1b --> P1
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
    Journal, Combination therapy, PD(L)-1 Biomarker, IO biomarker:  Pembrolizumab in mCRPC - Combination therapies as breakthrough to success? (Pubmed Central) -  Aug 21, 2023   
    This decision is not related to safety. ICI monotherapy seems to be effective in a small biomarker-preselected population, however, there is evidence that especially novel ICI combination approaches can improve patient survival, which could ultimately refocus and revolutionize the treatment of mCRPC.
  • ||||||||||  acapatamab (AMG 160) / Amgen, BeiGene
    Trial completion, Trial completion date, Trial primary completion date, Metastases:  Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC (clinicaltrials.gov) -  Jul 12, 2023   
    P1,  N=212, Completed, 
    ICI monotherapy seems to be effective in a small biomarker-preselected population, however, there is evidence that especially novel ICI combination approaches can improve patient survival, which could ultimately refocus and revolutionize the treatment of mCRPC. Active, not recruiting --> Completed | Trial completion date: May 2025 --> Jul 2023 | Trial primary completion date: May 2025 --> Jul 2023
  • ||||||||||  zeluvalimab (AMG 404) / Amgen, acapatamab (AMG 160) / Amgen, BeiGene
    Enrollment change, Metastases:  Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) -  May 22, 2023   
    P1/2,  N=65, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: May 2025 --> Jul 2023 | Trial primary completion date: May 2025 --> Jul 2023 N=136 --> 65
  • ||||||||||  acapatamab (AMG 160) / Amgen, BeiGene
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) -  Nov 22, 2022   
    P1b,  N=3, Terminated, 
    Trial completion date: Jul 2025 --> Nov 2023 N=50 --> 3 | Trial completion date: Jun 2026 --> Jan 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2026 --> Dec 2021; Amgen made a business decision to discontinue AMG 160 20180273
  • ||||||||||  acapatamab (AMG 160) / Amgen, BeiGene
    Enrollment closed:  Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) -  Jun 23, 2022   
    P1b,  N=50, Active, not recruiting, 
    N=50 --> 3 | Trial completion date: Jun 2026 --> Jan 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2026 --> Dec 2021; Amgen made a business decision to discontinue AMG 160 20180273 Recruiting --> Active, not recruiting
  • ||||||||||  acapatamab (AMG 160) / Amgen, BeiGene
    Trial completion date, Trial primary completion date:  Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) -  Apr 19, 2022   
    P1b,  N=50, Recruiting, 
    Recruiting --> Active, not recruiting Trial completion date: Feb 2026 --> Jun 2026 | Trial primary completion date: Feb 2026 --> Jun 2026
  • ||||||||||  acapatamab (AMG 160) / Amgen, BeiGene
    Trial completion date, Trial primary completion date, Metastases:  Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC (clinicaltrials.gov) -  Mar 4, 2022   
    P1,  N=288, Recruiting, 
    These data support the ongoing clinical evaluation of AMG 160 in patients with mCRPC. Trial completion date: Oct 2025 --> Jun 2025 | Trial primary completion date: Oct 2025 --> Jun 2025
  • ||||||||||  acapatamab (AMG 160) / Amgen
    Journal:  BiTE-ing into prostate cancer with bispecific T cell engagers. (Pubmed Central) -  Jan 1, 2022   
    Targeting prostate-specific membrane antigen (PSMA) has important therapeutic ramifications, more recently including immune oncology. Data were recently presented on the preclinical efficacy of a half-life extended bispecific T cell engager, AMG 160, which binds PSMA and CD3 to induce T cell-driven cytolytic activity against prostate cancer.
  • ||||||||||  acapatamab (AMG 160) / Amgen, BeiGene
    Trial completion date, Trial primary completion date, Metastases:  Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC (clinicaltrials.gov) -  Oct 4, 2021   
    P1,  N=288, Recruiting, 
    Data were recently presented on the preclinical efficacy of a half-life extended bispecific T cell engager, AMG 160, which binds PSMA and CD3 to induce T cell-driven cytolytic activity against prostate cancer. Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Apr 2025 --> Dec 2025
  • ||||||||||  acapatamab (AMG 160) / Amgen, BeiGene
    Enrollment open:  Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer (clinicaltrials.gov) -  Sep 30, 2021   
    P1b,  N=50, Recruiting, 
    Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Apr 2025 --> Dec 2025 Not yet recruiting --> Recruiting
  • ||||||||||  acapatamab (AMG 160) / Amgen
    [VIRTUAL] Targeting the Tumor Neovasculature in Lung Cancer: A Phase I Study of AMG 160 in Subjects With Non - Small Cell Lung Cancer (ePoster Hall) -  Aug 9, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_1103;    
    P1
    Detectable PSMA expression by 68Gallium-PSMA-11 PET/CT imaging, and an ECOG score of 0–2 are additional key inclusion criteria. Key exclusion criteria: presence of symptomatic brain metastases, active autoimmune disease, diseases requiring chronic systemic corticosteroid or immunosuppressive therapy.The study will enroll 10 patients with R/R non-squamous NSCLC in the dose exploration phase and ≥40 patients with R/R squamous and non-squamous NSCLC in the dose expansion phase across sites in the US, Australia, and Europe.
  • ||||||||||  zeluvalimab (AMG 404) / Amgen, acapatamab (AMG 160) / Amgen, BeiGene
    Trial completion date, Metastases:  Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) -  Jul 1, 2021   
    P1,  N=105, Recruiting, 
    Key exclusion criteria: presence of symptomatic brain metastases, active autoimmune disease, diseases requiring chronic systemic corticosteroid or immunosuppressive therapy.The study will enroll 10 patients with R/R non-squamous NSCLC in the dose exploration phase and ≥40 patients with R/R squamous and non-squamous NSCLC in the dose expansion phase across sites in the US, Australia, and Europe. Trial completion date: Sep 2025 --> May 2025
  • ||||||||||  zeluvalimab (AMG 404) / Amgen, acapatamab (AMG 160) / Amgen, BeiGene
    Trial completion date, Trial primary completion date, Metastases:  Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) -  Jun 3, 2021   
    P1,  N=105, Recruiting, 
    Trial completion date: Jan 2025 --> Apr 2025 | Trial primary completion date: Jan 2025 --> Apr 2025 Trial completion date: Sep 2026 --> Sep 2025 | Trial primary completion date: Jan 2025 --> Apr 2025