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词条 Tislelizumab
释义

  1. Clinical trials

  2. Pharmacokinetics

  3. References

{{Infobox drug
| type = mab
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| mab_type = mab
| source = zu
| target = PD-1
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| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 0KVO411B3N
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| KEGG = D11487
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| synonyms = BGB-A317
}}Tislelizumab[1][2] (BGB-A317) is a humanized monoclonal antibody directed against PD-1.[3] It prevents PD-1 from binding to the ligands PD-L1 and PD-L2 (hence it is a checkpoint inhibitor). It is being investigated as a treatment for advanced solid tumors.[3]

It is designed to bind less to Fc gamma receptors.[5]

It is being developed by BeiGene and Celgene Corp.[6]

Clinical trials

Phase I trials began in the US and Australia in June 2015 and were expected to complete in mid-2017.[4] Some early results were announced in July 2016.[5][3]

A pivotal phase 2 clinical trial for urothelial cancer started in China in 2017.[6]

It is in a phase 3 trial for NSCLC.[7]

A multicenter phase 3 trial for advanced hepatocellular carcinoma started in Jan 2018.[8]

Pharmacokinetics

Early phase I clinical trial results give an elimination half-life of 11 to 17 days.[3]

References

1. ^BGB-A317
2. ^BeiGene Presents Initial Phase 1b Data for BTK Inhibitor Zanubrutinib (BGB-3111) Combined with PD-1 Antibody Tislelizumab (BGB-A317) ... Dec 2017
3. ^A phase I dose-escalation study of BGB-A317, an anti-programmed death-1 (PD-1) mAb in patients with advanced solid tumors. ASCO 2016
4. ^[https://clinicaltrials.gov/show/NCT02407990 Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Subjects With Advanced Tumors]
5. ^[https://immuno-oncologynews.com/2016/07/26/beigene-presents-initial-clinical-data-showing-anti-cancer-activity-in-range-of-solid-tumors/ Early Results of Immunotherapy Study Showing Anti-Cancer Activity in Range of Solid Tumors July 2016]
6. ^[https://www.streetinsider.com/Corporate+News/BeiGene+%28BGNE%29+Commences+Pivotal+Trial+of+PD-1+Antibody+BGB-A317+in+China+in+Patients+with+Urothelial+Cancer/13068864.html BeiGene (BGNE) Commences Pivotal Trial of PD-1 Antibody BGB-A317 in China in Patients with Urothelial Cancer. July 2017]
7. ^[https://clinicaltrials.gov/ct2/show/NCT03358875 Comparison of Efficacy and Safety of Anti-PD-1 Antibody BGB-A317 Versus Docetaxel as Treatment in the Second- or Third-line Setting in Patients With NSCLC]
8. ^[https://globenewswire.com/news-release/2018/01/02/1276905/0/en/BeiGene-Initiates-Global-Phase-3-Trial-of-Anti-PD-1-Antibody-Tislelizumab-in-Patients-with-Hepatocellular-Carcinoma.html BeiGene Initiates Global Phase 3 Trial of Anti-PD-1 Antibody Tislelizumab in Patients with Hepatocellular Carcinoma Jan 2018]
{{monoclonals for immune system}}

2 : Monoclonal antibodies|Experimental drugs

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