Drug intelligence / Profile preview

azd0022 + cetuximab

Development stage
Unknown
Lead developer
AstraZeneca
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Oral, Intravenous
01

Overview

AZD0022 + cetuximab is an investigational combination therapy under clinical evaluation for solid tumors harboring the KRAS-G12D mutation, particularly in advanced non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. AZD0022 is a potent, oral, KRAS-G12D-selective small molecule inhibitor, developed to block mutant KRAS signaling and inhibit tumor growth. Cetuximab is a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), which is often overexpressed in solid tumors. Preclinical models demonstrate that combining AZD0022 with cetuximab results in enhanced anti-tumor efficacy, including sustained tumor regressions. This combination is currently being investigated in the ALAFOSS-01 Phase I/IIa first-in-human clinical trial to assess safety, tolerability, pharmacokinetics, and preliminary efficacy[2][4][5][10].

02

Targets

EGFR T790M (Epidermal growth factor receptor T790M mutant)KRASG12D (Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutant)

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