# CLARITY-Gastric 01

Source: https://onco.cc/trials/clarity-gastric01/  
OnCo record `clarity-gastric01` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first ADC against Claudin 18.2 to prove it extends life, announced July 2026, giving stomach cancer its first ADC beyond HER2.

## Summary

CLARITY-Gastric 01, trial NCT06346392 sponsored by AstraZeneca and announced in July 2026, is the first phase 3 to prove that an antibody-drug conjugate against Claudin 18.2 extends life, giving stomach cancer its first ADC beyond HER2. It randomised 594 patients with second- or later-line CLDN18.2-positive advanced gastric or gastro-oesophageal junction cancer to sonesitatug vedotin, also known as AZD0901 or CMG901, or investigator's choice chemotherapy, and met its co-primary overall survival endpoint in third-line or later disease, with survival in the whole population also significant and progression-free survival trending favourably; full data await presentation. OnCo links it to gastric and oesophageal cancer, Claudin 18.2 as a target, sonesitatug vedotin and ramucirumab. Whether the drug works after zolbetuximab is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT06346392
- Phase: 3
- Setting: Second- or later-line CLDN18.2-positive advanced gastric/GEJ cancer: sonesitatug vedotin (AZD0901/CMG901) vs investigator's choice
- Sponsor: AstraZeneca
- Enrolled: 594
- Result: Co-primary endpoints including OS met (July 2026); numbers pending.
- Outcomes: Overall survival, third-line or later (dual primary): Sonesitatug vedotin 2.2 mg/kg vs Investigator's choice chemotherapy; Progression-free survival (BICR), second-line or later (dual primary): Sonesitatug vedotin 2.2 mg/kg vs Investigator's choice chemotherapy
- Replication: First phase 3 OS win for a CLDN18.2 ADC; builds on the phase 1 KYM901 signal and on zolbetuximab (SPOTLIGHT/GLOW) validating the target in first line. Numbers awaited.

## Sources

- ClinicalTrials.gov NCT06346392: https://clinicaltrials.gov/study/NCT06346392
- ASCO GI 2025 trial-in-progress: https://ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.TPS507

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/)
- targets: [Claudin 18.2](https://onco.cc/targets/cldn18-2/)
- drugs: [Ramucirumab](https://onco.cc/drugs/ramucirumab/), [Sonesitatug vedotin](https://onco.cc/drugs/cmg901/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)
- pairings: [CLDN18.2 antibody first line → CLDN18.2 ADC or CAR-T on progression](https://onco.cc/pairings/cldn18-antibody-then-adc/)

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JSON: https://onco.cc/api/v1/entities/clarity-gastric01.json