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    DRUG:

    CS1002 (ipilimumab biosimilar)

    i
    Other names: SHR8068, SHR 8068, CS1002, CS-1002, CS 1002, SHR-8068
    Company:
    CStone Pharma, Jiangsu Hengrui Pharma
    Drug class:
    CTLA4 inhibitor
    Related drugs:
    7d
    A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma (clinicaltrials.gov)
    P1/2, N=90, Recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    CS1002 (ipilimumab biosimilar) • SHR-A2102 • Ariely (adebrelimab)
    2ms
    CS1002-101: A Study of CS1002 in Subjects with Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=91, Completed, CStone Pharmaceuticals | Phase classification: P1a/1b --> P1
    Phase classification • Combination therapy • Metastases
    |
    CS1002 (ipilimumab biosimilar) • nofazinlimab (CS1003)
    9ms
    Dual CTLA-4 and PD-1 checkpoint blockade using CS1002 and CS1003 (nofazinlimab) in patients with advanced solid tumors: A first-in-human, dose-escalation, and dose-expansion study. (PubMed, Cancer)
    CS1002 is a human immunoglobulin (Ig) G1 monoclonal antibody that blocks the interaction of CTLA-4 with its ligands and increases T-cell activation/proliferation. CS1003, now named nofazinlimab, is a humanized, recombinant IgG4 monoclonal antibody that blocks the interaction between human PD-1 and its ligands. In this original article, we determined the safety profile of CS1002 as monotherapy and in combination with CS1003. Furthermore, we explored the antitumor activity of the combination in anti-programmed cell death protein (ligand)-1 (PD-[L]1)-naive microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) pan tumors, and anti-PD-(L)1-refractory melanoma and hepatocellular carcinoma (HCC). CS1002 in combination with CS1003 had manageable safety profile across a broad dosing range and showed promising antitumor activities across CS1002 dose levels when combined with CS1003. This supports further assessment of CS1002 in combination with CS1003 for the treatment of solid tumors.
    P1 data • Journal • Checkpoint inhibition • Checkpoint block • Metastases
    |
    MSI (Microsatellite instability) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    MSI-H/dMMR
    |
    CS1002 (ipilimumab biosimilar) • nofazinlimab (CS1003)
    almost4years
    Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, National Cancer Institute (NCI) | N=40 --> 15 | Trial primary completion date: Dec 2020 --> Jul 2020
    Clinical • Enrollment change • Trial primary completion date • IO biomarker
    |
    ALB (Albumin)
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib) • CS1002 (ipilimumab biosimilar)
    almost4years
    Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer (clinicaltrials.gov)
    Trial completion date: Jan 2021 --> Jan 2022 | Trial primary completion date: Jan 2021 --> Jan 2022
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    ALB (Albumin)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet) • Cometriq (cabozantinib capsule) • CS1002 (ipilimumab biosimilar)