Drug intelligence / Profile preview

ALTA3263 + cetuximab

Development stage
Phase 1
Lead developer
Alterome Therapeutics
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral
01

Overview

ALTA3263 + cetuximab is an investigational combination regimen consisting of ALTA3263, an orally bioavailable, KRAS-selective, pan-mutant (ON/OFF) inhibitor, and cetuximab, an approved anti-EGFR monoclonal antibody. Developed by Alterome Therapeutics, the combination is designed to target KRAS-mutant solid tumors. ALTA3263 potently inhibits a broad range of oncogenic KRAS mutations in both active (ON) and inactive (OFF) states while sparing wild-type HRAS and NRAS. Cetuximab blocks EGFR signaling, which preclinically has shown synergistic antitumor activity when combined with KRAS inhibition in colorectal and pancreatic cancer models. The combination is being evaluated in a Phase 1/1b clinical trial (NCT06835569) for patients with advanced solid tumors harboring KRAS mutations, with an initial focus on colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC).

Other names
ALTA-3263 + cetuximabALTA-3263 + ErbituxALTA3263 + Erbitux
02

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