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    DRUG:

    eciskafusp alfa (RG6279)

    i
    Other names: RG6279, PD1 IL2v, PD1-IL2v, RO7284755, RO 7284755, RG-6279, RG 6279, RO-7284755
    Associations

    News

    Trials
    Company:
    Roche
    Drug class:
    PD1 inhibitor, IL-2βγR agonist
    Related drugs:
    Associations

    News

    Trials
    1d
    Target receptor expression dictates the selective intra-tumoral targeting of CD8+ T cells by eciskafusp alfa in matched PBMCs and TILs from CPI-naïve patients. (PubMed, Front Immunol)
    These findings provide translational validation for PD1-IL2v's mechanism, demonstrating selective intra-tumoral immune stimulation while minimizing Treg activation. This characterization identifies PD-1 receptor density and subset prevalence as critical factors for drug activity and represents potentially useful biomarkers for predicting patient responsiveness and guiding patient selection.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha)
    |
    eciskafusp alfa (RG6279)
    16d
    A Study to Evaluate Safety and Anti-Tumor Activity of Eciskafusp Alfa (RO7284755) Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=189, Terminated, Hoffmann-La Roche | Completed --> Terminated; After risk/benefit analysis, there was a very low probability (4.4%) of meeting the prespecified gating criteria for the Objective Response Rate at the final analysis.
    Trial termination • Tumor mutational burden • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Tecentriq (atezolizumab) • eciskafusp alfa (RG6279)
    7ms
    A Study to Evaluate Safety and Anti-Tumor Activity of Eciskafusp Alfa (RO7284755) Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=189, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed | Trial completion date: Aug 2026 --> Oct 2025 | Trial primary completion date: Jan 2026 --> Oct 2025
    Trial completion • Trial completion date • Trial primary completion date • Tumor mutational burden • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Tecentriq (atezolizumab) • eciskafusp alfa (RG6279)
    9ms
    PD-1-Cis IL-2R Agonism Determines the Predicted Pharmacological Dose Range for the Immunocytokine Eciskafusp Alfa (PD1-IL2v). (PubMed, CPT Pharmacometrics Syst Pharmacol)
    Furthermore, binding in cis-configuration is expected to follow a "bell-shaped" relationship with drug concentration such that high concentrations may lead to reduced benefit/risk ratio compared with concentrations around the peak of the bell-shape. Model simulations identify patient cohorts for whom the upper limit of the pharmacological dosing range may be defined by either undesirable off-tumor target engagement or a decrease in on-tumor cis-binding.
    Journal
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IL2RA (Interleukin 2 receptor, alpha)
    |
    eciskafusp alfa (RG6279)
    1year
    A Study to Evaluate Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)
    P1, N=0, Withdrawn, Hoffmann-La Roche | N=110 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    eciskafusp alfa (RG6279)
    1year
    A Study to Evaluate Safety and Anti-Tumor Activity of Eciskafusp Alfa (RO7284755) Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=189, Active, not recruiting, Hoffmann-La Roche | Trial completion date: May 2027 --> Aug 2026 | Trial primary completion date: Nov 2026 --> Jan 2026
    Trial completion date • Trial primary completion date • Tumor mutational burden • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Tecentriq (atezolizumab) • eciskafusp alfa (RG6279)
    1year
    A Study to Evaluate Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)
    P1, N=110, Recruiting, Hoffmann-La Roche | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    eciskafusp alfa (RG6279)
    over1year
    A Study to Evaluate Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)
    P1, N=110, Not yet recruiting, Hoffmann-La Roche | Phase classification: P1/2 --> P1
    Phase classification
    |
    eciskafusp alfa (RG6279)
    over1year
    A Study to Evaluate Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)
    P1/2, N=110, Not yet recruiting, Hoffmann-La Roche
    New P1/2 trial
    |
    eciskafusp alfa (RG6279)
    2years
    A Study to Evaluate Safety and Anti-Tumor Activity of Eciskafusp Alfa (RO7284755) Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=189, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    Tecentriq (atezolizumab) • eciskafusp alfa (RG6279)
    over2years
    A Study to Evaluate Safety and Anti-Tumor Activity of Eciskafusp Alfa (RO7284755) Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=256, Recruiting, Hoffmann-La Roche | Phase classification: P1a/1b --> P1 | Trial completion date: Nov 2026 --> May 2027 | Trial primary completion date: May 2026 --> Nov 2026
    Phase classification • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Tecentriq (atezolizumab) • eciskafusp alfa (RG6279)
    over3years
    A Study to Evaluate Safety and Anti-Tumor Activity of RO7284755 Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
    P1a/1b, N=348, Recruiting, Hoffmann-La Roche | Trial completion date: Jun 2027 --> Nov 2026 | Trial primary completion date: Mar 2027 --> May 2026
    Trial completion date • Trial primary completion date • Combination therapy • Tumor mutational burden • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • TCF7 (Transcription Factor 7)
    |
    PD-L1 expression
    |
    Tecentriq (atezolizumab) • eciskafusp alfa (RG6279)