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    DRUG CLASS:

    ICOS agonist

    Related drugs:
    2ms
    Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Feladilimab (GSK3359609) in Participants With RRMM (clinicaltrials.gov)
    P1/2, N=25, Active, not recruiting, GlaxoSmithKline
    New P1/2 trial
    |
    Blenrep (belantamab mafodotin-blmf) • feladilimab (GSK3359609)
    4ms
    First-in-human phase 1 study of the ICOS agonist feladilimab on patients with advanced solid tumors. (PubMed, J Immunother Cancer)
    This study showed the feasibility of a modified Toxicity Proportion Interval design and PK/PD analysis to determine a recommended dose for a compound without a dose-limiting toxicity and a tolerable and manageable safety profile.
    P1 data • Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • ICOS (Inducible T Cell Costimulator)
    |
    feladilimab (GSK3359609)
    6ms
    Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 2 (clinicaltrials.gov)
    P2, N=8, Terminated, GlaxoSmithKline | Initiation date: Jan 2019 --> Mar 2021
    Trial initiation date
    |
    Yervoy (ipilimumab) • feladilimab (GSK3359609)
    11ms
    Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 2 (clinicaltrials.gov)
    P2, N=8, Terminated, GlaxoSmithKline
    New P2 trial
    |
    Yervoy (ipilimumab) • feladilimab (GSK3359609)
    1year
    Safety and Efficacy of KY1044 and Atezolizumab in Advanced Cancer (clinicaltrials.gov)
    P1/2, N=222, Terminated, Kymab Limited | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
    Trial termination • Combination therapy • Metastases
    |
    Tecentriq (atezolizumab) • alomfilimab (SAR445256)
    1year
    INDUCE-4: Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=117, Terminated, GlaxoSmithKline | Phase classification: P2/3 --> P3
    Phase classification
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • feladilimab (GSK3359609)
    over1year
    INDUCE-3: Study of GSK3359609 and Pembrolizumab in Programmed Death Receptor 1-ligand 1 (PD-L1) Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=315, Terminated, GlaxoSmithKline | Phase classification: P2/3 --> P3
    Phase classification • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • feladilimab (GSK3359609)
    over1year
    Vopratelimab (JTX-2011) Alone and in Combination With Anti-Programmed Cell Death Protein 1 (PD-1) or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) in Subjects With Advanced and/or Refractory Solid Tumors (clinicaltrials.gov)
    P1/2, N=4, Terminated, Jounce Therapeutics, Inc. | Completed --> Terminated; Sponsor decision to discontinue providing study drug to patients who have been on study treatment for more than two years
    Trial termination • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • vopratelimab (JTX-2011)
    over1year
    Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen (clinicaltrials.gov)
    P2, N=69, Terminated, Jounce Therapeutics, Inc. | Active, not recruiting --> Terminated; The Sponsor decided to discontinue development of pimivalimab prior to the planned study completion. At the time of the decision to discontinue development, enrollment in the study had been completed.
    Trial termination
    |
    pimivalimab (JTX-4014) • vopratelimab (JTX-2011)
    over1year
    Safety and Efficacy of KY1044 and Atezolizumab in Advanced Cancer (clinicaltrials.gov)
    P1/2, N=280, Active, not recruiting, Kymab Limited | Trial completion date: Apr 2024 --> Aug 2024 | Trial primary completion date: Apr 2024 --> Aug 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Tecentriq (atezolizumab) • alomfilimab (SAR445256)
    over1year
    Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing Regimen (clinicaltrials.gov)
    P2, N=69, Active, not recruiting, Jounce Therapeutics, Inc. | Trial primary completion date: Sep 2022 --> May 2024
    Trial primary completion date • Combination therapy • IO biomarker • Metastases
    |
    pimivalimab (JTX-4014) • vopratelimab (JTX-2011)
    2years
    INDUCE-4: Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2/3, N=118, Terminated, GlaxoSmithKline | Active, not recruiting --> Terminated; The trial was stopped by the sponsor based on assessment of the clinical data
    Trial termination • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • feladilimab (GSK3359609)