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sonesitatug vedotin + capecitabine + rilvegostomig
- Development stage
- Phase 3
- Lead developer
- AstraZeneca
- Modality
- Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Small Molecules
- Administration
- Intravenous, Oral
01
Overview
CMG901 + capecitabine + rilvegostomig is an investigational combination regimen being evaluated for the first-line treatment of Claudin 18.2-positive, HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma. The regimen consists of three distinct therapeutic agents: sonesitatug vedotin (CMG901/AZD0901), a first-in-class antibody-drug conjugate (ADC) targeting Claudin 18.2 conjugated to the cytotoxic microtubule inhibitor monomethyl auristatin E (MMAE); capecitabine, an oral fluoropyrimidine chemotherapy prodrug that is metabolized to 5-fluorouracil to inhibit thymidylate synthase; and rilvegostomig (AZD2936), a bispecific monoclonal antibody designed to simultaneously block the PD-1 and TIGIT immune checkpoint pathways. This combination is currently being evaluated in the global Phase III CLARITY-Gastric 02 trial sponsored by AstraZeneca, which licensed the global rights to CMG901 from KYM Biosciences (a joint venture of Keymed Biosciences and Lepu Biopharma) in 2023.
- Other names
- sonesitatug vedotin and rilvegostomig with capecitabinesonesitatug vedotin in combination with capecitabine with or without rilvegostomig
02
Targets
Claudin 18.2PDCD1 (Programmed cell death protein 1 receptor)TIGIT (T cell immunoreceptor with Ig and ITIM domains)TS (Thymidylate synthase)
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