AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
Start Date
12/13/2023
Completion Date
6/28/2027
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. Substudy 3 will investigate the safety, tolerability, and anti-tumour activity of AZD0901 monotherapy in participants with advanced or metastatic Biliary tract cancer.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
AZD0901
5-Fluorouracil
Leucovorin
l-leucovorin
Irinotecan
Nanoliposomal Irinotecan
Gemcitabine
Conditions
Locations
Research Site
Orange, California 92868
United States
Research Site
Palo Alto, California 94304
United States
Research Site
Santa Rosa, California 95403
United States
Research Site
Louisville, Kentucky 40202
United States
Research Site
Commack, New York 11725
United States
Research Site
Providence, Rhode Island 02903
United States
Research Site
Houston, Texas 77030
United States
Research Site
Melbourne, 3000
Australia
Research Site
Murdoch, WA6150
Australia
Research Site
Randwick, 2031
Australia
Research Site
Kingston, Ontario K7L 2V7
Canada
Research Site
Toronto, Ontario M5G 2M9
Canada
Research Site
Montreal, Quebec H3G 1A4
Canada
Research Site
Sherbrooke, Quebec J1G 2E8
Canada
Research Site
Changsha, 410013
China
Research Site
Chengdu, 610041
China
Research Site
Tbilisi, 0112
Georgia
Research Site
Chūōku, 104-0045
Japan
Research Site
Kashiwa, 227-8577
Japan
Research Site
Kitaadachi-gun, 362-0806
Japan
Research Site
Kōtoku, 135-8550
Japan
Research Site
Nagoya, 464-8681
Japan
Research Site
Osakasayama-shi, 589-8511
Japan
Research Site
George Town, 10450
Malaysia
Research Site
Johor Bahru, 81100
Malaysia
Research Site
Kuala Lumpur, 59100
Malaysia
Research Site
Kuala Selangor, 62250
Malaysia
Research Site
Kuching, 93586
Malaysia
Research Site
Chisinau, MD-2025
Moldova
Research Site
Krakow, 31-501
Poland
Research Site
Warsaw, 02-034
Poland
Research Site
Bukit Merah, 169610
Singapore
Research Site
Singapore, 119074
Singapore
Research Site
Singapore, 308433
Singapore
Research Site
Singapore, 329563
Singapore
Research Site
Gyeonggi-do, 13620
South Korea
Research Site
Seoul, 03080
South Korea
Research Site
Seoul, 03722
South Korea
Research Site
Seoul, 05505
South Korea
Research Site
Seoul, 06351
South Korea
Research Site
Barcelona, 08035
Spain
Research Site
Madrid, 28007
Spain
Research Site
Madrid, 28040
Spain
Research Site
Kaohsiung City, 80756
Taiwan
Research Site
Taichung, 404
Taiwan
Research Site
Tainan, 70403
Taiwan
Research Site
Taipei, 11217
Taiwan
Research Site
Taoyuan, 00333
Taiwan
Research Site
Glasgow, G12 0YN
United Kingdom
Research Site
Leeds, LS9 7TF
United Kingdom
Research Site
London, NW3 2QG
United Kingdom
Research Site
Oxford, OX3 7LE
United Kingdom