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AZD0901 + volrustomig + fluoropyrimidine

Development stage
Unknown
Lead developer
AstraZeneca
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous, Oral
01

Overview

AZD0901 + volrustomig + fluoropyrimidine is an investigational combination regimen for the treatment of advanced solid tumors expressing Claudin 18.2, notably gastric, gastroesophageal junction, or pancreatic cancers. **AZD0901** is an antibody-drug conjugate targeting Claudin18.2, conjugated to monomethyl auristatin E (MMAE), delivering cytotoxicity directly to CLDN18.2-positive tumor cells via targeted internalization and release of MMAE; it also induces immune-mediated cell killing (ADCC and CDC)[2][3][4]. **Volrustomig** is a bispecific monoclonal antibody targeting PD-1 and TIGIT immune checkpoints, designed to enhance anti-tumor immune responses (current public data confirms its role as a dual checkpoint inhibitor)[8]. **Fluoropyrimidine** (e.g., 5-fluorouracil) is a classic chemotherapy agent inhibiting thymidylate synthase, thereby blocking DNA synthesis and repair in rapidly dividing cells[6]. This combination is being evaluated in clinical trials aiming to exploit direct tumor cell cytotoxicity (ADC), heightened immune checkpoint inhibition, and cytotoxic chemotherapy in tumors resistant to standard therapies. The primary developer and manufacturer is **AstraZeneca**[5][6][8].

Brand names
CMG901CMG-901CMG 901
Other names
Sonesitatug Vedotin5-Fluorouracil5-FU
02

Targets

Claudin 18.2TS (Thymidylate synthase)

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