Drug intelligence / Profile preview

sintilimab + IBI310 + capecitabine + oxaliplatin

Development stage
Phase 3
Lead developer
Innovent Biologics
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral
01

Overview

This investigational regimen is a combination therapy consisting of two immune checkpoint inhibitors and a doublet chemotherapy backbone. **Sintilimab** (also known as cindilimab) is a fully human IgG4 monoclonal antibody that targets the programmed cell death protein 1 (PD-1) receptor, blocking its interaction with PD-L1 and PD-L2 to restore anti-tumor T-cell activity. **IBI310** is a monoclonal antibody targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), providing complementary immune checkpoint blockade similar to the ipilimumab/nivolumab paradigm. The chemotherapy component, **CapeOx** (or XELOX), consists of **capecitabine**, an oral fluoropyrimidine carbamate prodrug of 5-fluorouracil, and **oxaliplatin**, a platinum-based antineoplastic agent that forms DNA cross-links. The combination is primarily being evaluated as a neoadjuvant therapy for patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) locally advanced rectal adenocarcinoma.

Other names
Cindilimab + IBI310 + capecitabine + oxaliplatinSintilimab + IBI310 + CapeOxSintilimab + IBI310 + XELOX
02

Targets

CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)DNAPDCD1 (Programmed cell death protein 1 receptor)TS (Thymidylate synthase)

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