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    DRUG:

    falbikitug (AZD0171)

    i
    Other names: AZD0171, MSC-1, MSC 1, MSC1, AZD-0171, AZD 0171
    Associations

    News

    Trials
    Company:
    AstraZeneca, Boehringer Ingelheim
    Drug class:
    LIF inhibitor
    Related drugs:
    Associations

    News

    Trials
    3d
    Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours (clinicaltrials.gov)
    P2, N=126, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2025 --> Jun 2026
    Trial completion date
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • falbikitug (AZD0171)
    2ms
    Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours (clinicaltrials.gov)
    P2, N=126, Active, not recruiting, AstraZeneca | Trial completion date: Aug 2025 --> Dec 2025
    Trial completion date
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • falbikitug (AZD0171)
    12ms
    Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours (clinicaltrials.gov)
    P2, N=126, Active, not recruiting, AstraZeneca | Trial completion date: Oct 2024 --> Aug 2025
    Trial completion date
    |
    Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • falbikitug (AZD0171)
    over1year
    NeoCOAST-2: Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=490, Recruiting, AstraZeneca | Trial completion date: Dec 2029 --> May 2030 | Trial primary completion date: Dec 2029 --> May 2030
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • Datroway (datopotamab deruxtecan-dlnk) • oleclumab (MEDI9447) • volrustomig (MEDI5752) • falbikitug (AZD0171) • monalizumab (IPH2201)
    over1year
    NeoCOAST-2: Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=490, Recruiting, AstraZeneca | Trial completion date: Dec 2028 --> Dec 2029 | Trial primary completion date: Dec 2028 --> Dec 2029
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • Datroway (datopotamab deruxtecan-dlnk) • oleclumab (MEDI9447) • volrustomig (MEDI5752) • falbikitug (AZD0171) • monalizumab (IPH2201)
    over1year
    A mechanistic PK/PD model of AZD0171 (anti-LIF) to support Phase II dose selection. (PubMed, CPT Pharmacometrics Syst Pharmacol)
    The aim of this work was to develop a mechanistic PK/PD model to investigate the effect of AZD0171 on tumor LIF levels, predict the level of downstream signaling complex (LIF:LIFR:gp130) inhibition, and examine the dose-response relationship to support dose selection for a Phase II clinical study. Modeling results show that tumor LIF is inhibited in a dose-dependent manner with >90% inhibition for 95% of patients at the Phase II clinical dose of 1500 mg Q2W.
    P2 data • PK/PD data • Journal
    |
    IL6 (Interleukin 6) • STAT3 (Signal Transducer And Activator Of Transcription 3) • LIFR (LIF Receptor Subunit Alpha) • LIF (LIF Interleukin 6 Family Cytokine)
    |
    falbikitug (AZD0171)
    almost2years
    NeoCOAST-2: Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=490, Recruiting, AstraZeneca | N=350 --> 490
    Enrollment change
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • Datroway (datopotamab deruxtecan-dlnk) • oleclumab (MEDI9447) • volrustomig (MEDI5752) • falbikitug (AZD0171) • monalizumab (IPH2201)
    over2years
    Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours (clinicaltrials.gov)
    P2, N=126, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    CD8 (cluster of differentiation 8) • CA 19-9 (Cancer antigen 19-9)
    |
    Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • falbikitug (AZD0171)
    over2years
    NeoCOAST-2: Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=350, Recruiting, AstraZeneca | Trial completion date: Mar 2026 --> Dec 2028 | Trial primary completion date: Mar 2026 --> Dec 2028
    Trial completion date • Trial primary completion date • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • Datroway (datopotamab deruxtecan-dlnk) • oleclumab (MEDI9447) • volrustomig (MEDI5752) • falbikitug (AZD0171) • monalizumab (IPH2201)
    almost3years
    Safety, Pharmacokinetics and Clinical Activity of AZD0171 in Combination With Durvalumab and Chemotherapy in Locally Advanced or Metastatic Solid Tumours (clinicaltrials.gov)
    P2, N=115, Recruiting, AstraZeneca | Trial completion date: Oct 2023 --> Nov 2024 | Trial primary completion date: Oct 2023 --> Nov 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    CD8 (cluster of differentiation 8) • CA 19-9 (Cancer antigen 19-9)
    |
    Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • falbikitug (AZD0171)
    almost3years
    NeoCOAST-2: Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=350, Recruiting, AstraZeneca | N=210 --> 350
    Enrollment change • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • pemetrexed • Datroway (datopotamab deruxtecan-dlnk) • oleclumab (MEDI9447) • volrustomig (MEDI5752) • falbikitug (AZD0171) • monalizumab (IPH2201)
    3years
    Therapeutic targeting of LIF overcomes macrophage mediated immunosuppression of the local tumor microenvironment. (PubMed, Clin Cancer Res)
    Overall, our findings highlight LIF as a therapeutic target for cancer immunotherapy.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    LIFR (LIF Receptor Subunit Alpha)
    |
    falbikitug (AZD0171)