Actively Recruiting
AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
Led by AstraZeneca · Updated on 2026-02-12
224
Participants Needed
52
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older or the legal age of consent.
- Participants must test positive for CLDN18.2.
- At least one measurable tumor lesion according to RECIST v1.1.
- ECOG performance status of 0 to 1 with no worsening in the last 2 weeks before dosing.
- Predicted life expectancy of at least 12 weeks.
- Adequate organ and bone marrow function as defined by the study protocol.
- Body weight greater than 35 kg.
- Willingness to comply with contraception requirements.
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction for Sub study 1.
- Advanced or metastatic gastric or gastroesophageal junction cancer for Sub study 1.
- Maximum of 2 prior systemic treatments for unresectable or metastatic disease for Sub study 1.
- Histologically confirmed metastatic or advanced pancreatic ductal adenocarcinoma for Sub study 2.
- Availability of an archival or fresh tumor biopsy sample for Sub study 2.
- No prior treatments for unresectable or metastatic disease in Sub study 2; prior neoadjuvant/adjuvant chemotherapy allowed if progression occurred at least 6 months after last dose.
- Histologically confirmed, unresectable advanced, or metastatic biliary tract adenocarcinoma (including cholangiocarcinoma and gallbladder carcinoma) for Sub study 3.
- Disease progression documented after at least one prior treatment regimen and up to 2 prior systemic treatments for unresectable or metastatic disease for Sub study 3.
You will not qualify if you...
- Unstable or active peptic ulcer disease or digestive tract bleeding, including significant bleeding related to prior CLDN18.2 therapy.
- Clinically significant ascites requiring drainage.
- History of drug-induced non-infectious interstitial lung disease or pneumonitis.
- Presence of central nervous system metastases or other CNS pathology.
- Peripheral neuropathy grade 2 or higher at screening.
- History of another primary cancer.
- Prior exposure to any MMAE-based antibody-drug conjugate.
- Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.
- For Sub study 1: HER2-positive or indeterminate gastric/gastroesophageal cancer unless standard anti-HER2 therapy failed, was not tolerated, or not suitable.
- Factors increasing risk of QTc prolongation or arrhythmia.
- Use of medications known to prolong QT/QTc interval.
- For Sub study 2: Known DPD enzyme deficiency.
- Use of strong inhibitors or inducers of UGT1A1 or CYP3A4.
- Known homozygous UGT1A1*28 allele.
- For Sub study 3: Clinically significant biliary obstruction not resolved before enrollment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
Research Site
Orange, California, United States, 92868
Actively Recruiting
2
Research Site
Palo Alto, California, United States, 94304
Actively Recruiting
3
Research Site
Santa Rosa, California, United States, 95403
Actively Recruiting
4
Research Site
Louisville, Kentucky, United States, 40202
Actively Recruiting
5
Research Site
Commack, New York, United States, 11725
Actively Recruiting
6
Research Site
Providence, Rhode Island, United States, 02903
Actively Recruiting
7
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
8
Research Site
Melbourne, Australia, 3000
Actively Recruiting
9
Research Site
Murdoch, Australia, WA6150
Actively Recruiting
10
Research Site
Randwick, Australia, 2031
Actively Recruiting
11
Research Site
Kingston, Ontario, Canada, K7L 2V7
Withdrawn
12
Research Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
13
Research Site
Montreal, Quebec, Canada, H3G 1A4
Actively Recruiting
14
Research Site
Sherbrooke, Quebec, Canada, J1G 2E8
Actively Recruiting
15
Research Site
Changsha, China, 410013
Not Yet Recruiting
16
Research Site
Chengdu, China, 610041
Not Yet Recruiting
17
Research Site
Tbilisi, Georgia, 0112
Actively Recruiting
18
Research Site
Chūōku, Japan, 104-0045
Actively Recruiting
19
Research Site
Kashiwa, Japan, 227-8577
Actively Recruiting
20
Research Site
Kitaadachi-gun, Japan, 362-0806
Actively Recruiting
21
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
22
Research Site
Nagoya, Japan, 464-8681
Actively Recruiting
23
Research Site
Osakasayama-shi, Japan, 589-8511
Actively Recruiting
24
Research Site
George Town, Malaysia, 10450
Actively Recruiting
25
Research Site
Johor Bahru, Malaysia, 81100
Completed
26
Research Site
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
27
Research Site
Kuala Selangor, Malaysia, 62250
Actively Recruiting
28
Research Site
Kuching, Malaysia, 93586
Actively Recruiting
29
Research Site
Chisinau, Moldova, MD-2025
Actively Recruiting
30
Research Site
Krakow, Poland, 31-501
Actively Recruiting
31
Research Site
Warsaw, Poland, 02-034
Actively Recruiting
32
Research Site
Bukit Merah, Singapore, 169610
Actively Recruiting
33
Research Site
Singapore, Singapore, 119074
Actively Recruiting
34
Research Site
Singapore, Singapore, 308433
Actively Recruiting
35
Research Site
Singapore, Singapore, 329563
Actively Recruiting
36
Research Site
Gyeonggi-do, South Korea, 13620
Actively Recruiting
37
Research Site
Seoul, South Korea, 03080
Actively Recruiting
38
Research Site
Seoul, South Korea, 03722
Actively Recruiting
39
Research Site
Seoul, South Korea, 05505
Actively Recruiting
40
Research Site
Seoul, South Korea, 06351
Actively Recruiting
41
Research Site
Barcelona, Spain, 08035
Actively Recruiting
42
Research Site
Madrid, Spain, 28007
Actively Recruiting
43
Research Site
Madrid, Spain, 28040
Actively Recruiting
44
Research Site
Kaohsiung City, Taiwan, 80756
Actively Recruiting
45
Research Site
Taichung, Taiwan, 404
Actively Recruiting
46
Research Site
Tainan, Taiwan, 70403
Actively Recruiting
47
Research Site
Taipei, Taiwan, 11217
Actively Recruiting
48
Research Site
Taoyuan, Taiwan, 00333
Actively Recruiting
49
Research Site
Glasgow, United Kingdom, G12 0YN
Withdrawn
50
Research Site
Leeds, United Kingdom, LS9 7TF
Withdrawn
51
Research Site
London, United Kingdom, NW3 2QG
Withdrawn
52
Research Site
Oxford, United Kingdom, OX3 7LE
Withdrawn
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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