AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
Recruiting now Phase 2 NCT06219941
Run by AstraZeneca · for 18 and older · All sexes
What this study is about
The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2.
Who can join (things the study team will check)
The list below is a summarised eligibility criteria for the study - refer to the study protocol for full criteria. Master Inclusion Criteria applicable to all sub studies: * Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF. * Participants who are CLDN18.2 positive. * Must have at least one measurable lesion according to RECIST v1.1. * ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing. * Predicted life expectancy of ≥ 12 weeks. * Adequate organ and bone marrow function as defined by protocol. * Body weight \> 35 kg. * Participants are willing to comply with contraception requirements. Sub study 1 Specific Inclusion criteria: * Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction. * Advanced or metastatic GC/GEJC. * Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease. Sub study 2 Specific Inclusion criteria: * Participants diagnosed with histologically confirmed metastatic or advanced PDAC. * Availability of an archival sample or a fresh tumour biopsy taken at screening. * No prior treatments for unresectable or metasta…
Where this trial is running
- Research Site, Orange, California, United States
- Research Site, Palo Alto, California, United States
- Research Site, Santa Rosa, California, United States
- Research Site, Louisville, Kentucky, United States
- Research Site, Commack, New York, United States
- Research Site, Providence, Rhode Island, United States
- Research Site, Houston, Texas, United States
- Research Site, Melbourne, Australia
- Research Site, Murdoch, Australia
- Research Site, Randwick, Australia
- Research Site, Kingston, Ontario, Canada
- Research Site, Toronto, Ontario, Canada
+ 40 more sites.
Who to contact
AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06219941.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.