drugset / Trial / NCT06346392
AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.
Timeline
- Start
- 2024-03-04
- Primary completion
- 2026-05-31
- Completion
- 2026-10-14
Publications
- Yu J, Mehta R. Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257036. doi: 10.6004/jnccn.2025.7036.
- Xu G, Liu W, Wang Y, Wei X, Liu F, He Y, Zhang L, Song Q, Li Z, Wang C, Xu R, Chen B. CMG901, a Claudin18.2-specific antibody-drug conjugate, for the treatment of solid tumors. Cell Rep Med. 2024 Sep 17;5(9):101710. doi: 10.1016/j.xcrm.2024.101710. Epub 2024 Sep 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Comparator | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Comparator | Ramucirumab | Monoclonal antibody | 8 mg/kg | Intravenous |
| Comparator | Rivoceranib | Small molecule | 500 mg | Oral |
| Comparator | Rivoceranib | Small molecule | 850 mg | Oral |
| Subject | Sonesitatug Vedotin | Other / unclassified | — | Intravenous |
| Comparator | TAS-102 | Small molecule | 35 mg/m2 | Oral |
| Comparator | TAS-102 | Small molecule | 80 mg | Oral |