Drug intelligence / Profile preview

D-1553 + cetuximab

Development stage
Phase 2
Lead developer
InventisBio
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Oral, Intravenous
01

Overview

D-1553 + cetuximab is a combination therapy for advanced or metastatic solid tumors with a KRAS G12C mutation, particularly in colorectal cancer (CRC). **D-1553 (garsorasib)** is a potent, selective, oral small molecule inhibitor targeting the KRAS G12C mutant protein. By inhibiting KRAS G12C, it disrupts oncogenic signaling through the RAS–MEK and PI3K–AKT pathways, suppressing tumor growth. **Cetuximab** is an anti-EGFR monoclonal antibody that blocks epidermal growth factor receptor signaling, frequently used in CRC. This combination is under clinical evaluation for patients who have failed standard regimens, especially those with locally advanced/metastatic CRC with KRAS G12C mutations, and has recently received Breakthrough Therapy Designation in China for this indication[2][1][3].

Brand names
garsorasib
Other names
D-1553 + cetuximab
02

Targets

EGFR (Epidermal growth factor receptor)KRASG12C (Kirsten rat sarcoma viral oncogene homolog G12C)

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