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D3 Bio Receives U.S. FDA Clearance for Two IND Applications, Enabling Phase 1 Trial of D3S‑003 and Phase 2 Combination Study of Elisrasib (D3S‑001) with D3S‑002

  • D3 Bio announced that the FDA has cleared two Investigational New Drug applications for D3S‑003 and a combination study involving D3S‑001 and D3S‑002.
  • The U.S. Food and Drug Administration has cleared two Investigational New Drug applications from D3 Bio.
  • With this clearance, D3 Bio will start a Phase 1 trial of D3S‑003 in patients with advanced solid tumors that have KRAS G12D mutations.
  • A Phase 2 study will analyze the combination of D3S‑001 and D3S‑002 in patients with KRAS G12C–mutant non‑small cell lung cancer .
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D3 Bio Receives U.S. FDA Clearance for Two IND Applications, Enabling Phase 1 Trial of D3S‑003 and Phase 2 Combination Study of Elisrasib (D3S‑001) with D3S‑002

SHANGHAI, Jan. 18, 2026 /PRNewswire/ -- D3 Bio, a global clinical‑stage biotechnology company focused on developing transformative oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared two Investigational New Drug (IND) applications:

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PR Newswire broke the news in Chicago, United States on Monday, January 19, 2026.
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