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CStone Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009 (PD-1/VEGF/CTLA-4) to Advance into Phase II Clinical Trial

  • CStone has received FDA clearance to start a global Phase II clinical trial for its novel trispecific antibody, CS2009, according to Dr. Jason Yang, CEO of CStone.
  • The FDA reviewed Phase I data on safety and antitumor activity and agreed on key Phase II study design elements, including dose optimization.
  • CS2009 targets PD-1, VEGFA, and CTLA-4 to deliver multidimensional antitumor effects through synergistic actions.
  • The ongoing Phase II trial is multi-cohort, testing CS2009 as monotherapy and in combination, enrolling patients in Australia and China, with IND clearance in the U.S..
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The Berkshire EagleThe Berkshire Eagle
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CStone Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009 (PD-1/VEGF/CTLA-4) to Advance into Phase II Clinical Trial

CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical trial in patients with advanced solid tumors. This marks a significant milestone in the global…

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PR Newswire broke the news in United States on Monday, February 16, 2026.
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