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Phase 1/2a Open-Label, Dose-Escalation, Multicenter, First-in-Human, Consecutive-Cohort, Clinical Trial of BI-1910, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2), as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

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Trial Profile

Phase 1/2a Open-Label, Dose-Escalation, Multicenter, First-in-Human, Consecutive-Cohort, Clinical Trial of BI-1910, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2), as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 05 Mar 2025

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At a glance

  • Drugs BI-1910 (Primary) ; Pembrolizumab (Primary)
  • Indications Liver cancer; Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors BioInvent International

    • Most Recent Events

    • 27 Feb 2025 According to a BioInvent International media release, company announced Phase 1 data from Part B, dose escalation of BI-1910 in combination with pembrolizumab expected H2 2025
    • 27 Feb 2025 According to a BioInvent International media release, First BI-1910 Phase 2a single agent data expected H2 2025
    • 08 Jan 2025 According to a BioInvent International media release, Phase 2a studying BI-1910 as single agent is planned to start in H1 2025 and will be performed in several tumor types including HCC (hepatocellular cancer) patients. Early results indicate favorable pharmacokinetic data, and patients in the target dose range are showing evidence of induction of T cell proliferation.

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