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

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

Outcome

Mixed primary results

release “该试验不仅达到了三线及后线治疗OS这一双主要终点” keymedbio.com ↗

release “在另一项由盲态独立中心审查（BICR）评估的PFS双主要终点方面，结果显示二线及后线治疗患者的PFS呈现改善趋势，未达到统计学显著性。” keymedbio.com ↗

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

Indications