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    DRUG:

    IBI-310 (ipilimumab biosimilar)

    i
    Other names: IBI-310, IBI310, IBI 310
    Associations

    News

    Trials
    Company:
    Innovent Biologics
    Drug class:
    CTLA4 inhibitor
    Related drugs:
    Associations

    News

    Trials
    2ms
    Neoadjuvant treatment of IBI310 plus sintilimab in locally advanced MSI-H/dMMR colon cancer: A randomized phase 1b study. (PubMed, Cancer Cell)
    One death occurred in each arm due to postoperative complication and adverse events. These findings demonstrate the added benefit of neoadjuvant IBI310 plus sintilimab over sintilimab monotherapy for locally advanced MSI-H/dMMR colon cancer.
    P1 data • Journal • MSI-H • dMMR
    |
    MSI (Microsatellite instability) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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    MSI-H/dMMR
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    Tyvyt (sintilimab) • IBI-310 (ipilimumab biosimilar)
    8ms
    PD-L1 Antibody Combined With CTLA-4 Antibody for Patients With Advanced Intrahepatic Cholangiocarcinoma Who Progressed After Standard Treatment (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, Shanghai Zhongshan Hospital | Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Sep 2025
    Enrollment closed • Trial completion date
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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    AiRuiLi (adebrelimab) • IBI-310 (ipilimumab biosimilar)
    8ms
    A Study to Evaluate the Similarity in Pharmacokinetics and Safety of IBI310 and Ipilimumab（YERVOY）in Adult Healthy Chinese Male Volunteers (clinicaltrials.gov)
    P1, N=148, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    Yervoy (ipilimumab) • IBI-310 (ipilimumab biosimilar)
    9ms
    Sintilimab Combined with IBI310 and Surufatinib for the Treatment of G3-NET and NEC (NESSIE) (clinicaltrials.gov)
    P2, N=30, Recruiting, Peking University | Trial completion date: Mar 2025 --> Sep 2025 | Trial primary completion date: Mar 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression
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    Tyvyt (sintilimab) • Sulanda (surufatinib) • IBI-310 (ipilimumab biosimilar)
    1year
    IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR)/microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=4, Terminated, Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting --> Terminated; After careful consideration, our company has decided to revise the overall development strategy for IBI310 and discontinue further registration research for this project. Consequently, the ongoing screening process will be terminated, and this decisi
    Trial termination • Combination therapy • Mismatch repair • Metastases
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    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Tyvyt (sintilimab) • IBI-310 (ipilimumab biosimilar)
    1year
    Efficacy and Safety of IBI310 Combined with Sintilimab in Patients with Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P1, N=97, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting --> Completed | Trial completion date: Apr 2023 --> Jun 2024 | Trial primary completion date: Apr 2023 --> Jun 2024
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    Tyvyt (sintilimab) • IBI-310 (ipilimumab biosimilar)
    over1year
    Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers (clinicaltrials.gov)
    P2, N=38, Recruiting, Peking University
    New P2 trial
    |
    Tyvyt (sintilimab) • Lenvima (lenvatinib) • IBI-310 (ipilimumab biosimilar)
    over1year
    A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer (clinicaltrials.gov)
    P3, N=360, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Phase classification: P1b --> P3 | N=100 --> 360
    Phase classification • Enrollment change • Combination therapy • Mismatch repair
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    MSI (Microsatellite instability)
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    MSI-H/dMMR
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    Tyvyt (sintilimab) • IBI-310 (ipilimumab biosimilar)
    almost2years
    A phase Ib study evaluating the safety and efficacy of IBI310 plus sintilimab in patients with advanced non-small-cell lung cancer who have progressed after anti-PD-1/L1 therapy. (PubMed, Cancer Med)
    IBI310 3 mg/kg Q3W plus sintilimab was effective in a small number of previously treated anti-PD-1/L1-resistant NSCLC patients.
    P1 data • Journal • Metastases
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Tyvyt (sintilimab) • IBI-310 (ipilimumab biosimilar)
    almost2years
    A Phase II Clinical Study to Assess the Efficacy and Safety of IBI310 or Placebo Combined With Sintilimab for Advanced Cervical Cancer Subjects Who Have Failed or Cannot Tolerate First-line or Above Platinum-based Chemotherapy (clinicaltrials.gov)
    P2, N=205, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Nov 2023 | Trial primary completion date: Feb 2024 --> Nov 2023
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    Tyvyt (sintilimab) • IBI-310 (ipilimumab biosimilar)
    over2years
    A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer (clinicaltrials.gov)
    P1b, N=100, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Mismatch repair
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Tyvyt (sintilimab) • IBI-310 (ipilimumab biosimilar)
    over2years
    A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer (clinicaltrials.gov)
    P1b, N=100, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
    New P1 trial • Combination therapy • Mismatch repair
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Tyvyt (sintilimab) • IBI-310 (ipilimumab biosimilar)