D3 Bio has received the US Food and Drug Administration (FDA) clearance for two investigational new drug (IND) applications, enabling clinical trials of kirsten rat sarcoma viral oncogene homolog (KRAS) inhibitors.
The approvals permit a Phase I first-in-human trial of D3S 003, a KRAS G12D inhibitor, and a Phase II combination study of elisrasib (D3S 001) with D3S 002.
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The Phase I trial will involve patients with advanced solid tumours harbouring KRAS G12D mutations.
D3 Bio’s Phase II trial will assess the early efficacy, safety and pharmacokinetics of combining elisrasib, a next-generation KRAS G12C inhibitor, with D3S 002, a selective oral extracellular signal-regulated kinase (ERK) 1/2 inhibitor.
It will focus on patients with KRAS G12C–mutant non-small cell lung cancer (NSCLC) who have progressed after previous KRAS G12C targeted therapies. The trial is scheduled to start in the first half of 2026.
D3S 003 targets both the GDP-bound (OFF) and GTP-bound (ON) conformations.
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By GlobalDataElisrasib is being assessed globally in Phase II monotherapy and combination trials across KRAS G12C–mutant solid tumours, including colorectal cancer and NSCLC.
D3 Bio founder, chairman and CEO George Chen said: “We are excited to receive FDA IND clearance for D3S 003 and to advance a Phase II combination clinical trial of elisrasib and D3S 002. With D3S 003, we are bringing a differentiated KRAS G12D inhibitor into the clinic to address one of the most prevalent and challenging KRAS mutations.
“In parallel, the combination study of elisrasib and D3S 002 pushes forward our next-generation KRAS G12C strategy, particularly for patients who have progressed on prior KRAS G12C targeted therapies.
“Together, these milestones underline the momentum of our KRAS franchise and reinforce our commitment to delivering transformative therapies for patients with KRAS mutant cancers who urgently need new options.”
