Actively Recruiting
Study for AZD4360 in Participants With Advanced Solid Tumours
Led by AstraZeneca · Updated on 2026-04-23
117
Participants Needed
18
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.
CONDITIONS
Official Title
Study for AZD4360 in Participants With Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years or older at time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 without recent deterioration
- Minimum life expectancy of 12 weeks as judged by investigator
- Adequate organ and marrow function per protocol definitions
- Use of contraception consistent with local regulations
- Histologically confirmed advanced or metastatic pancreatic ductal adenocarcinoma, gastric or gastroesophageal junction cancer, or biliary tract cancer with positive CLDN18.2 expression
- Received at least one prior line of systemic therapy for advanced/metastatic disease
- At least one measurable lesion according to RECIST v1.1
You will not qualify if you...
- HER2 positive or indeterminate status in gastric or gastroesophageal junction cancer
- Unstable or active peptic ulcer disease or digestive tract bleeding, including significant bleeding related to prior CLDN18.2 therapy
- Clinically significant ascites requiring drainage
- Central nervous system metastases or pathology
- Spinal cord compression or high risk of paralysis
- History of non-infectious interstitial lung disease or pneumonitis
- Cardiac abnormalities as defined by protocol
- History of another primary malignancy within 2 years prior to screening
- Active hepatitis B or hepatitis C infection
- HIV infection that is not well controlled
- Active tuberculosis infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Research Site
Santa Monica, California, United States, 90404
Actively Recruiting
2
Research Site
Providence, Rhode Island, United States, 02903
Actively Recruiting
3
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
4
Research Site
Beijing, China, 100730
Actively Recruiting
5
Research Site
Chengdu, China, 610041
Actively Recruiting
6
Research Site
Shanghai, China, 201318
Actively Recruiting
7
Research Site
Wuhan, China, 430040
Actively Recruiting
8
Research Site
Berlin, Germany, 12200
Not Yet Recruiting
9
Research Site
Dresden, Germany, 01307
Actively Recruiting
10
Research Site
Frankfurt, Germany, 60488
Actively Recruiting
11
Research Site
Chūōku, Japan, 104-0045
Actively Recruiting
12
Research Site
Kashiwa, Japan, 227-8577
Actively Recruiting
13
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
14
Research Site
Sendai, Japan, 980-8574
Not Yet Recruiting
15
Research Site
Glasgow, United Kingdom, G12 0YN
Not Yet Recruiting
16
Research Site
Leeds, United Kingdom, LS9 7TF
Not Yet Recruiting
17
Research Site
London, United Kingdom, EC1A 7BE
Actively Recruiting
18
Research Site
Oxford, United Kingdom, OX3 7LE
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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