Drug intelligence / Profile preview

IBI343 + capecitabine + oxaliplatin

Development stage
Phase 2
Lead developer
Innovent Biologics
Modality
Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral
01

Overview

IBI343 + capecitabine + oxaliplatin is an investigational combination regimen being evaluated for the treatment of Claudin 18.2 (CLDN18.2)-positive advanced pancreatic cancer. The primary component, IBI343, is an antibody-drug conjugate (ADC) developed by Innovent Biologics, consisting of a recombinant humanized anti-CLDN18.2 monoclonal antibody conjugated to the topoisomerase I inhibitor payload exatecan via a cleavable linker. This is combined with capecitabine, an oral fluoropyrimidine carbamate that acts as a prodrug of 5-fluorouracil, and oxaliplatin, a platinum-based antineoplastic agent that forms DNA cross-links. The combination is currently being studied in a Phase Ib/II trial sponsored by Zhejiang Cancer Hospital to assess safety and efficacy in patients who have progressed on first-line gemcitabine-based therapy. IBI343 has received Breakthrough Therapy Designation from China's NMPA for pancreatic cancer based on early clinical data.

02

Targets

Claudin 18.2DNATS (Thymidylate synthase)

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