Drug intelligence / Profile preview

IBI363 + capecitabine + oxaliplatin

Development stage
Phase 2
Lead developer
Innovent Biologics
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Small Molecules
Administration
Intravenous, Oral
01

Overview

IBI363 + capecitabine + oxaliplatin is an investigational combination regimen that pairs the novel biologic IBI363 with the standard-of-care XELOX (CAPOX) chemotherapy backbone. IBI363 (also known as TAK-928) is a potential first-in-class PD-1/alpha-biased IL-2 bispecific fusion protein developed by Innovent Biologics in global partnership with Takeda. It is designed to simultaneously block the PD-1/PD-L1 checkpoint pathway and selectively activate the IL-2 pathway on tumor-specific T cells, minimizing systemic toxicity by reducing binding to IL-2Rβ and IL-2Rγ. Capecitabine is an oral fluoropyrimidine carbamate prodrug of 5-fluorouracil, and oxaliplatin is an intravenous platinum-based alkylating agent. This combination is being evaluated in clinical trials, including an investigator-initiated Phase 1b study (NCT06610799), as a first-line treatment for patients with HER2-negative advanced or unresectable gastric or gastroesophageal junction adenocarcinoma.

Other names
IBI363 + CAPOXIBI363 + oxaliplatin + capecitabineIBI363 + XELOXTAK-928 + CAPOXTAK-928 + XELOXTAK-928 + capecitabine + oxaliplatinTAK-928 + oxaliplatin + capecitabine
02

Targets

DNAIL2RA (Interleukin-2 receptor alpha subunit)IL2RB (IL-2 receptor beta chain)IL2RG (Interleukin-2 receptor gamma subunit)PDCD1 (Programmed cell death protein 1 receptor)CD274 (Programmed cell death protein 1 ligand 1)TS (Thymidylate synthase)

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