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    DRUG:

    Sym021

    i
    Other names: Sym021, Sym 021, S95016, S-95016, Sym-021, S 95016
    Associations

    News

    Trials
    Company:
    Servier, Takeda
    Drug class:
    PD1 inhibitor
    Related drugs:
    Associations

    News

    Trials
    12d
    Phase Ib multicenter study of anti-TIM-3 (S095018/Sym023) in combination with anti-PD-1 (Sym021) in patients with advanced/metastatic recurrent biliary tract cancer. (PubMed, J Immunother Cancer)
    Dual PD-1/TIM-3 inhibition was tolerable but exhibited modest antitumor activity in patients with advanced/metastatic recurrent BTC who had not received prior anti-PD-(L)1 treatment.
    Clinical • P1 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • PD-L2 (Programmed Cell Death 1 Ligand 2)
    |
    S95018 • Sym021
    5ms
    CL1-95029-001: S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov)
    P1, N=51, Active, not recruiting, Institut de Recherches Internationales Servier | Trial completion date: Jun 2025 --> Mar 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    BRAF V600E • KRAS wild-type
    |
    futuximab/modotuximab (S95026) • S95029 • Sym021
    over1year
    CL1-95029-001: S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov)
    P1, N=51, Active, not recruiting, Institut de Recherches Internationales Servier | Trial completion date: Jan 2025 --> Jun 2025
    Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    BRAF V600E • KRAS wild-type • KRAS exon 2 mutation • KRAS exon 2 wild-type
    |
    futuximab/modotuximab (S95026) • S95029 • Sym021
    over1year
    Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov)
    P1, N=48, Completed, Symphogen A/S | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    S95024 • Sym021
    over1year
    S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov)
    P1, N=51, Active, not recruiting, Institut de Recherches Internationales Servier | Trial completion date: Jul 2024 --> Jan 2025
    Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    futuximab/modotuximab (S95026) • S95029 • Sym021
    over1year
    Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov)
    P1, N=78, Completed, Symphogen A/S | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    irinotecan • S95018 • Sym021 • Sym022
    almost2years
    Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov)
    P1, N=78, Active, not recruiting, Symphogen A/S | N=148 --> 78 | Trial completion date: Jan 2025 --> Jun 2024
    Enrollment change • Trial completion date • Combination therapy • Metastases
    |
    FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation • FGFR2 mutation • FGFR2 fusion
    |
    irinotecan • S95018 • Sym021 • Sym022
    almost2years
    Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov)
    P1, N=48, Active, not recruiting, Symphogen A/S | N=100 --> 48
    Enrollment change • Combination therapy • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    S95024 • Sym021
    almost2years
    Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov)
    P1, N=100, Active, not recruiting, Symphogen A/S | Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Jul 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    S95024 • Sym021
    almost2years
    S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov)
    P1, N=51, Active, not recruiting, Institut de Recherches Internationales Servier | Trial completion date: Feb 2024 --> Jul 2024
    Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    BRAF V600E • KRAS wild-type • KRAS exon 2 mutation • KRAS exon 2 wild-type
    |
    futuximab/modotuximab (S95026) • S95029 • Sym021
    2years
    Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov)
    P1, N=148, Active, not recruiting, Symphogen A/S | Phase classification: P1b --> P1
    Phase classification
    |
    FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    IDH1 mutation • FGFR2 mutation • FGFR2 fusion
    |
    irinotecan • S95018 • Sym021 • Sym022
    2years
    S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov)
    P1, N=51, Active, not recruiting, Institut de Recherches Internationales Servier | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    BRAF V600E • KRAS wild-type • KRAS exon 2 mutation • KRAS exon 2 wild-type
    |
    futuximab/modotuximab (S95026) • S95029 • Sym021