Actively Recruiting
Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors
Led by AstraZeneca · Updated on 2026-02-24
280
Participants Needed
25
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of informed consent
- Histologically confirmed adenocarcinoma of the stomach, gastro-esophageal junction, esophagus, or pancreas
- At least one measurable tumor lesion by RECIST v1.1 criteria
- Positive CLDN18.2 expression on tumor cells confirmed by central immunohistochemistry
- ECOG performance status of 0 or 1 at screening
- Predicted life expectancy of 12 weeks or more
- Adequate organ and bone marrow function within 28 days prior to first dose
- Use of contraception by men or women as per local regulations
- Received at least one prior systemic therapy for advanced or metastatic disease
You will not qualify if you...
- Unresolved toxicity from prior anticancer therapy of Grade 2 or higher except as defined by protocol
- History of unacceptable cytokine release syndrome or neurotoxicity after prior T cell engager or CAR-T cell therapy
- Previous hemophagocytic lymphohistiocytosis or macrophage activation syndrome
- Active or past autoimmune or inflammatory disorders within 3 years before treatment
- Central nervous system metastases or pathology within 3 months prior to consent
- Active infections including HIV, hepatitis B or C, uncontrolled EBV, or systemic fungal or bacterial infections
- Cardiac conditions as defined by protocol
- Thromboembolic event within 3 months before first dose
- Need for chronic immunosuppressive therapy
- Use of long-acting or therapeutic-dose anticoagulants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Research Site
Jacksonville, Florida, United States, 32224
Actively Recruiting
2
Research Site
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
Research Site
New York, New York, United States, 10065
Withdrawn
4
Research Site
Beijing, China, 100142
Actively Recruiting
5
Research Site
Beijing, China, 101199
Actively Recruiting
6
Research Site
Shandong, China
Actively Recruiting
7
Research Site
Toulouse, France, 31059
Actively Recruiting
8
Research Site
Villejuif, France, 94805
Actively Recruiting
9
Research Site
Chūōku, Japan, 104-0045
Actively Recruiting
10
Research Site
Kashiwa, Japan, 227-8577
Actively Recruiting
11
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
12
Research Site
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
13
Research Site
Groningen, Netherlands, 9713 GZ
Actively Recruiting
14
Research Site
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
15
Research Site
Seoul, South Korea, 03080
Actively Recruiting
16
Research Site
Seoul, South Korea, 03722
Actively Recruiting
17
Research Site
Seoul, South Korea, 05505
Actively Recruiting
18
Research Site
Seoul, South Korea, 06351
Actively Recruiting
19
Research Site
Kaohsiung City, Taiwan, 80756
Actively Recruiting
20
Research Site
Tainan, Taiwan, 70403
Actively Recruiting
21
Research Site
Taoyuan, Taiwan, 00333
Actively Recruiting
22
Research Site
Dundee, United Kingdom, DD1 9SY
Actively Recruiting
23
Research Site
London, United Kingdom, E1 1BB
Actively Recruiting
24
Research Site
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
25
Research Site
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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