modakafusp alfa (TAK-573) / Takeda 
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  • ||||||||||  modakafusp alfa (TAK-573) / Takeda
    Trial completion, Enrollment change, Combination therapy:  iinnovate-2: A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma (clinicaltrials.gov) -  Jul 18, 2024   
    P1,  N=15, Completed, 
    Active, not recruiting --> Completed | N=58 --> 15 | Trial completion date: Mar 2025 --> May 2024 | Trial primary completion date: Mar 2025 --> May 2024 Active, not recruiting --> Completed | N=120 --> 15
  • ||||||||||  modakafusp alfa (TAK-573) / Takeda
    Trial completion date, Trial primary completion date, Combination therapy:  iinnovate-2: A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma (clinicaltrials.gov) -  Jun 3, 2024   
    P1,  N=120, Active, not recruiting, 
    Active, not recruiting --> Completed | N=120 --> 15 Trial completion date: Jan 2028 --> Jun 2024 | Trial primary completion date: Jul 2025 --> Jan 2024
  • ||||||||||  Review, Journal, IO biomarker:  New Therapies on the Horizon for Relapsed Refractory Multiple Myeloma. (Pubmed Central) -  Jan 12, 2024   
    Iberdomide and mezigdomide are cereblon E3 ligase modulators with higher potency, immunomodulatory, and antiproliferative activity compared with lenalidomide and pomalidomide...Modakafusp alfa is an immunocytokine that targets interferons to CD38+ cells. It has demonstrated single agent activity in relapsed/refractory MM in the phase 1 setting.
  • ||||||||||  modakafusp alfa (TAK-573) / Takeda
    Evaluation of the innate and adaptive immune modulatory properties and anti-tumor activity of CD38-targeted interferon alpha (Exhibit Hall B) -  Sep 27, 2023 - Abstract #SITC2023SITC_1374;    
    Background Modakafusp alfa is a novel immunocytokine therapy comprising two attenuated interferon alpha (IFN?) moieties fused to a humanized anti-CD38 IgG4 monoclonal antibody...Treatment with mCD38-mAtt increased the presence and activation of tumor antigen-specific CD8 T cells, which correlated with a reduction in tumor mass. Conclusions Taken together, these data indicate that mCD38-mAtt acts as an enhancer of both innate and adaptive immunity in immunocompetent mouse models that drives an anti-tumor immune response, independently of tumor CD38 expression.
  • ||||||||||  modakafusp alfa (TAK-573) / Takeda
    Rationale and design of three ongoing phase 1/2 trials of modakafusp alfa, an innate immunity enhancer, in patients with multiple myeloma: The iinnovate clinical development program (In Person) -  Sep 10, 2023 - Abstract #IMW2023IMW_477;    
    P1/2, P1b
    In the phase 2 iinnovate-1 extension study (NCT03215030), pts are randomized to receive moda 120 mg or 240 mg every four weeks to define the single-agent dose with the optimal benefit/risk profile in pts with ?3 prior lines of therapy (LoT) who are at least triple-class refractory (to an IMiD, a PI, and an anti-CD38 mAb)...In group 1, moda is combined with lenalidomide (len) as post-transplant maintenance therapy... The ongoing iinnovate-1-2-3 studies are assessing the optimal dose of moda as a single agent and as part of doublet and triplet combinations with SOC agents for different MM pt populations, including those with high unmet medical needs.
  • ||||||||||  modakafusp alfa (TAK-573) / Takeda
    Trial completion date, Trial primary completion date:  iinnovate-1: A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) -  May 22, 2023   
    P1/2,  N=336, Recruiting, 
    The ongoing iinnovate-1-2-3 studies are assessing the optimal dose of moda as a single agent and as part of doublet and triplet combinations with SOC agents for different MM pt populations, including those with high unmet medical needs. Trial completion date: Apr 2025 --> Sep 2024 | Trial primary completion date: May 2023 --> Mar 2024
  • ||||||||||  modakafusp alfa (TAK-573) / Takeda
    Enrollment open, Combination therapy:  iinnovate-3: A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) -  Dec 27, 2022   
    P1/2,  N=58, Recruiting, 
    iinnovate-3 (NCT05590377) is a phase 1/2a study to evaluate the safety, tolerability, and preliminary efficacy of moda in combination with dara SC...Two dose levels of moda in combination with dara will be selected for phase 2a optimal dose finding in pts who have received 1 Not yet recruiting --> Recruiting
  • ||||||||||  modakafusp alfa (TAK-573) / Takeda
    Final Results from the First-in-Human Phase 1/2 Study of Modakafusp Alfa, an Immune-Targeting Attenuated Cytokine, in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM) (ENMCC - New Orleans Theater C) -  Nov 4, 2022 - Abstract #ASH2022ASH_3576;    
    P1/2
    As dexamethasone (dex) is part of standard of care in MM, but could counteract the immune activation elicited by modakafusp, additional cohorts at 0.4 mg/kg Q3W and 1.5 mg/kg Q4W in combination with 40 mg dex QW were opened...Conclusions Modakafusp alfa has a novel mechanism of action, a manageable safety profile, and encouraging anti-myeloma activity at 1.5 mg/kg Q4W, independent of peripheral blood immune cell CD38 expression. A randomized phase 2 study to compare fixed-dose levels of 120 and 240 mg (equivalent to 1.5 and 3.0 mg/kg) Q4W and to define the single-agent dose with the optimal benefit/risk profile is currently enrolling.
  • ||||||||||  modakafusp alfa (TAK-573) / Takeda
    Enrollment change, Trial completion date, Trial primary completion date:  iinnovate-1: A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) -  Apr 28, 2022   
    P1/2,  N=336, Recruiting, 
    Q4W dosing is viable; the optimal dose and combinations are being investigated. N=151 --> 336 | Trial completion date: Feb 2022 --> Apr 2025 | Trial primary completion date: Feb 2022 --> May 2023