Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors
Start Date
7/11/2023
Completion Date
7/16/2027
Summary
This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.
Detailed Description
This is a first-time in human, modular Phase I/II, open-label multicentre study of AZD5863 monotherapy administered intravenously (Module 1), or AZD5863 monotherapy administered subcutaneously (Module 2) in patients with advanced or metastatic solid tumors. Each module contains dose-escalation (Part A) and dose-expansion (Part B).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
AZD5863
Conditions
Locations
Research Site
Jacksonville, Florida 32224
United States
Research Site
Rochester, Minnesota 55905
United States
Research Site
New York, New York 10065
United States
Research Site
Beijing, 100142
China
Research Site
Beijing, 101199
China
Research Site
Shandong,
China
Research Site
Toulouse, 31059
France
Research Site
Villejuif, 94805
France
Research Site
Chūōku, 104-0045
Japan
Research Site
Kashiwa, 227-8577
Japan
Research Site
Kōtoku, 135-8550
Japan
Research Site
Amsterdam, 1081 HV
Netherlands
Research Site
Groningen, 9713 GZ
Netherlands
Research Site
Rotterdam, 3015 GD
Netherlands
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
Kaohsiung City, 80756
Taiwan
Research Site
Tainan, 70403
Taiwan
Research Site
Taoyuan, 00333
Taiwan
Research Site
Dundee, DD1 9SY
United Kingdom
Research Site
London, E1 1BB
United Kingdom
Research Site
Metropolitan Borough of Wirral, CH63 4JY
United Kingdom
Research Site
Oxford, OX3 7LE
United Kingdom