Investigational Drug
AZD0901
TrialFetch AI Analysis
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Overview
AZD0901, also called sonesitatug vedotin or CMG901, is an investigational antibody–drug conjugate being studied primarily in claudin 18.2 (CLDN18.2)–expressing gastric and gastroesophageal junction cancers. Human results are available from phase 1 and phase 2 studies. A phase 3 trial has also reported preliminary results, but detailed comparative data have not yet been published. (sciencedirect.com)
Mechanism of action
The drug links an antibody targeting CLDN18.2 to monomethyl auristatin E (MMAE), a substance that disrupts the cellular structures needed for cell division. A cleavable linker is designed to release MMAE after the antibody–drug conjugate enters a target cell. (sciencedirect.com)
Efficacy
In the single-arm phase 1 KYM901 trial, 32 of 113 patients (28%) with advanced gastric or gastroesophageal junction cancer had a confirmed tumor response at doses of 2.2–3.0 mg/kg. In the phase 2 CLARITY-PanTumor01 study, the reported response rate was 28.4% among 67 patients receiving 2.2 mg/kg; median progression-free survival was 4.2 months. Neither study alone establishes how the drug compares with standard treatment. (em-consulte.com)
In July 2026, the sponsor announced that the randomized phase 3 CLARITY-Gastric01 trial found an overall-survival improvement versus investigators’ choice of treatment in previously treated CLDN18.2-expressing cancer. The announcement did not provide survival estimates or effect sizes. Its other primary endpoint, progression-free survival in the second-line-or-later population, did not reach statistical significance. These findings remain difficult to assess fully until detailed results are released. (astrazeneca.com)
Safety
In KYM901’s 107-patient dose-expansion group, 68% experienced a grade 3 or worse adverse event. The most common grade 3–4 events were decreased neutrophil count (21%), anemia (14%), and vomiting (10%); one treatment-related death was reported. In the phase 2 report, 34.3% of 67 patients had grade 3 or worse adverse events, and 40.3% required a dose reduction. The phase 3 announcement did not provide detailed safety rates. (em-consulte.com)
Further reading
- KYM901 phase 1 peer-reviewed report
- CLARITY-PanTumor01 phase 2 conference abstract
- Preclinical mechanism study
- CLARITY-Gastric01 preliminary phase 3 announcement
Last updated: Sep 2026
Active trials using AZD0901
Found 4 active trials using this drug:
TrialFetch AI summary: Adults with previously untreated, unresectable or metastatic CLDN18.2-positive, HER2-negative gastric, gastroesophageal junction, or distal esophageal adenocarcinoma receive first-line treatment according to PD-L1 status and checkpoint-inhibitor eligibility. The study compares capecitabine plus sonesitatug vedotin, a CLDN18.2-directed antibody–drug conjugate, with or without rilvegostomig, a PD-1/TIGIT-blocking antibody, against nivolumab-based chemotherapy or zolbetuximab-based or oxaliplatin-based chemotherapy.
ClinicalTrials.gov ID: NCT07431281
TrialFetch AI summary: Adults with CLDN18.2-positive, HER2-negative unresectable or metastatic gastric, gastroesophageal junction, or distal esophageal adenocarcinoma that has progressed after fluoropyrimidine- and platinum-containing therapy are randomized to intravenous AZD0901 or investigator’s choice of therapy. AZD0901 is an investigational CLDN18.2-targeted antibody–drug conjugate that delivers the microtubule-disrupting payload MMAE.
ClinicalTrials.gov ID: NCT06346392
TrialFetch AI summary: Adults with CLDN18.2-positive, unresectable advanced or metastatic gastric/gastroesophageal, pancreatic, or biliary tract adenocarcinoma receive AZD0901 (sonesitatug vedotin), a CLDN18.2-targeted antibody–drug conjugate carrying a microtubule-disrupting payload. It is given alone for gastric/gastroesophageal and biliary tract cancer, and with chemotherapy for pancreatic cancer; prior-treatment requirements vary by tumor type.
ClinicalTrials.gov ID: NCT06219941
TrialFetch AI summary: Adults with previously untreated, HER2-negative, unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma receive first-line combinations of chemotherapy with volrustomig (PD-1/CTLA-4), rilvegostomig (PD-1/TIGIT), or AZD7789 (PD-1/TIM-3), all investigational bispecific antibodies. Selected substudies instead pair one of these antibodies with the CLDN18.2-directed antibody–drug conjugate AZD0901 and fluoropyrimidine chemotherapy; these substudies require central CLDN18.2 testing.
ClinicalTrials.gov ID: NCT05702229
