Drug intelligence / Profile preview

ABBV-400 + fluorouracil + leucovorin + budigalimab

Development stage
Unknown
Lead developer
AbbVie
Modality
Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

ABBV-400 + fluorouracil + leucovorin + budigalimab is an experimental combination regimen under clinical investigation primarily for advanced or metastatic solid tumors, including metastatic colorectal cancer. - **ABBV-400** is an antibody-drug conjugate (ADC) consisting of a c-Met (MET proto-oncogene, receptor tyrosine kinase)-targeting antibody (telisotuzumab) conjugated to a novel topoisomerase 1 inhibitor payload. It is designed to selectively target and kill c-Met–overexpressing tumor cells via cytotoxic activity of the payload and antibody-mediated mechanisms[3]. - **Fluorouracil** (5-FU) is a cytotoxic small molecule acting as a thymidylate synthase inhibitor, commonly used in colorectal and other gastrointestinal cancers. - **Leucovorin** (folinic acid) is a reduced folate that enhances the effect of fluorouracil by stabilizing its binding to thymidylate synthase, improving efficacy. - **Budigalimab** is an experimental monoclonal antibody targeting programmed cell death protein 1 (PD-1), functioning as an immune checkpoint inhibitor to enhance antitumor immune responses. This multi-agent combination leverages targeted cytotoxicity (ABBV-400), standard cytotoxic chemotherapy (fluorouracil + leucovorin), and immune checkpoint blockade (budigalimab) for the potential treatment of c-Met–overexpressing tumors, with colorectal cancer as a key indication under clinical investigation[2][3].

02

Targets

TOP1 (DNA Topoisomerase I)PDCD1 (Programmed cell death protein 1 receptor)MET (Mesenchymal-epithelial transition factor receptor)TS (Thymidylate synthase)

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