D3 Bio Receives the US FDA IND Clearance to Initiate P-I trial of D3S-003 & P-II Combination Study of Elisrasib (D3S-001) with D3S-002
Shots:
- FDA has granted IND clearance to initiate D3S-003 a P-I, and a P-II combination study of D3S-001 (elisrasib), a next-gen KRAS G12C inhibitor, with D3S-002, an oral ERK1/2 inhibitor
- The P-II trial will evaluate the D3S-001 + D3S-002 combination in KRAS G12C–mutant NSCLC patients who have progressed on prior KRAS G12C therapies to assess safety, PK, and preliminary efficacy, aiming to overcome resistance and achieve more durable clinical benefit
- D3S-003 is an oral, allele-specific KRAS G12D inhibitor targeting both GDP- and GTP-bound states, showing better preclinical potency and safety, and will now advance into a P-I trial in KRAS G12D-mutant advanced solid tumors following FDA IND clearance
Ref: PR Newswire | Image: D3 Bio | Press Release
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