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Brief Title: AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
Official Title: A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2.
Study ID: NCT06219941
Brief Summary: 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.
Detailed Description: This open-label, multi-centre study consists of individual sub studies, each evaluating the safety and tolerability of AZD0901. Sub study 1 will investigate the safety, tolerability, and anti-tumour activity of AZD0901 monotherapy in participants with advanced or metastatic gastric esophageal cancer expressing CLDN18.2. Participants will receive AZD0901 monotherapy via intravenous (IV) infusion and will be randomised in to one of 2 arms. Sub study 2 will consist of two parts, a safety run-in and a dose expansion part to investigate the safety and efficacy of AZD0901 in combination with different chemotherapy agents in participants with pancreatic cancer.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Research Site, Montreal, Quebec, Canada
Research Site, Sherbrooke, Quebec, Canada
Research Site, Tbilisi, , Georgia
Research Site, Chuo-ku, , Japan
Research Site, Kashiwa, , Japan
Research Site, Kitaadachi-gun, , Japan
Research Site, Koto-ku, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Osakasayama-shi, , Japan
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, George Town, , Malaysia
Research Site, Johor Bahru, , Malaysia
Research Site, Kuala Lumpur, , Malaysia
Research Site, Kuching, , Malaysia
Research Site, Selangor, , Malaysia
Research Site, Chisinau, , Moldova, Republic of
Research Site, Bukit Merah, , Singapore
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Singapore, , Singapore
Research Site, Barcelona, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Kaohsiung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan City, , Taiwan
Research Site, Taipei City, , Taiwan
Research Site, Taoyuan, , Taiwan
Research Site, Glasgow, , United Kingdom
Research Site, Leeds, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Oxford, , United Kingdom