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Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-PD-L1 Monoclonal Antibody BGB-A333 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

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Trial Profile

Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-PD-L1 Monoclonal Antibody BGB-A333 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 21 Feb 2023

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At a glance

  • Drugs Garivulimab (Primary) ; Tislelizumab (Primary)
  • Indications Carcinoma; Gastric cancer; Head and neck cancer; Non-small cell lung cancer; Ovarian cancer; Renal cell carcinoma; Solid tumours; Squamous cell cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors BeiGene

    • Most Recent Events

    • 16 Feb 2023 Results of preliminary analysis assessing safety and efficacy of BGB-A333, alone and in combination with the PD-1 inhibitor, tislelizumab, in patients with advanced solid tumours published in the British Journal of Cancer
    • 12 Oct 2021 Primary end-points have been updated to change the timeframe from 3 years to 33.5 months and Number of Participants With Abnormal Electrocardiograms (ECG), Number of Participants With Abnormalities During Physical Examinations and Number of Participants With Abnormal Lab Assessment Results have been added as new primary end points. Time frame for RP2D is changed from 3 years to 28 months.
    • 06 May 2021 Status changed from active, no longer recruiting to discontinued and terminated early.
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