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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 .