Actively Recruiting
A Phase II Open-label Multi-centre Study Evaluating AZD0901 Alone and With Anti-cancer Agents in Advanced Solid Tumours Expressing Claudin 18.2
Led by AstraZeneca · Updated on 2026-02-12
224
Participants Needed
52
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AZD0901, an antibody-drug conjugate, for its safety, tolerability, effectiveness, how the body processes it, and immune response in people with advanced solid tumors that express the protein Claudin 18.2. This includes participants with locally advanced, unresectable, or metastatic tumors such as gastric, gastroesophageal junction, pancreatic ductal adenocarcinoma, and biliary tract cancers. The study is open-label and multi-centre, involving several sub-studies focused on different tumor types and treatment combinations. The study includes three main sub-studies: Sub Study 1 tests AZD0901 alone by intravenous infusion in participants with advanced gastric or gastroesophageal junction cancer, with participants randomized into two groups. Sub Study 2 evaluates AZD0901 combined with various chemotherapy drugs for pancreatic cancer, starting with a safety run-in followed by a dose expansion phase. Sub Study 3 assesses AZD0901 alone in participants with advanced biliary tract cancer. Treatments are given according to the sub-study design to investigate safety and anti-tumor activity. Participants will undergo regular assessments including monitoring for adverse events, lab tests, vital signs, ECGs, and physical exams during and after treatment. Researchers will measure tumor response, survival outcomes, drug levels in blood, and immune reactions over a period of about two years. Safety follow-up continues for 90 days after stopping AZD0901. The total study duration covers treatment and post-treatment observation to understand the treatment's impact and tolerability.
CONDITIONS
Brief Title
AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years or older who can legally consent
- Tumors must test positive for Claudin 18.2
- At least one measurable tumor lesion per RECIST v1.1 criteria
- ECOG performance status of 0 to 1 without recent decline
- Predicted life expectancy of at least 12 weeks
- Adequate organ and bone marrow function as defined by the protocol
- Body weight greater than 35 kg
- Willingness to comply with contraception requirements
- For Sub Study 1: Histologically confirmed advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, with up to 2 prior systemic treatments for unresectable or metastatic disease
- For Sub Study 2: Histologically confirmed metastatic or advanced pancreatic ductal adenocarcinoma, with no prior treatment for unresectable or metastatic disease; prior neoadjuvant/adjuvant chemotherapy allowed if progression occurred at least 6 months after last dose
- For Sub Study 3: Histologically confirmed unresectable advanced or metastatic biliary tract adenocarcinoma (excluding ampullary cancers) with disease progression after at least one prior regimen and up to 2 prior systemic treatments for unresectable or metastatic disease
You will not qualify if you...
- Unstable or active peptic ulcer disease or digestive tract bleeding, including significant bleeding after 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 pathology
- Peripheral neuropathy grade 2 or higher at screening
- History of another primary malignancy
- Prior exposure to MMAE-based antibody-drug conjugates
- Prior exposure to CLDN18.2 targeted agents other than anti-CLDN18.2 monoclonal antibody
- For Sub Study 1: HER2-positive or indeterminate gastric/gastroesophageal junction cancer unless standard anti-HER2 therapy has failed or is not suitable; factors increasing risk of QTc prolongation or arrhythmic events; use of medications prolonging QT/QTc interval
- For Sub Study 2: Known DPD enzyme deficiency; use of strong inhibitors or inducers of UGT1A1 or CYP3A4; homozygous UGT1A1*28 allele
- For Sub Study 3: Clinically significant unresolved biliary obstruction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years or until disease progression or discontinuation
Participants receive AZD0901 alone or in combination with chemotherapy agents to evaluate safety, tolerability, and anti-tumour activity.
Repeated visits for drug administration and assessments during treatment period
Duration - Up to 90 days post treatment completion for adverse event follow-up; overall survival monitored up to approximately 2 years
Participants are monitored for adverse events and survival after treatment ends.
Periodic visits for safety and survival assessments
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
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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