At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AZD4360 (drug)
- How long the study runs
- Study runs about 32 months (dates as stated)
- About the drug or intervention
- AZD4360 — drug: Antibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 130 Years
- Who
- All
- Number of participants
- 31
- Started
- 2025-04-29
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for gastric cancer
- • Phase1/Phase2 - 31 participants
- • 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
Who can take part?
- • Ages 18 Years to 130 Years
- • Diagnosed with gastric cancer
Where?
- • Glasgow - Research Site
- • London - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
Gastric CancerGastroesophageal Junction CancerBiliary Tract CancerPancreatic Ductal Adenocarcinoma
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 130 Years
- Who can join: All genders
Biomarkers mentioned
documented positiveHER2and positive
Treatment history
Treatments you must have had:
- ✓ received at least one prior line of systemic therapy in the advanced/metastatic disease
- ✓ of systemic therapy in the advanced/metastatic disease
What the study is looking for
- ✓Participant must be ≥ 18 at the time of signing the ICF.
- ✓activity scale performance status of 0-1 with no deterioration over the previous 2 weeks prior...
- ✓Minimum life expectancy of 12 weeks in the opinion of the Investigator.
- ✓4 Adequate organ and marrow function, as defined by protocol.
- ✓5\. Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.
Who cannot take part
- ✗Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ...
- ✗Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically...
- ✗Participants with clinically significant ascites that require drainage.
- ✗Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.
- ✗With spinal cord compression or with high risk of paralysis.
See the full criteria
Inclusion Criteria:
1. Participant must be ≥ 18 at the time of signing the ICF.
2. Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
3. Minimum life expectancy of 12 weeks in the opinion of the Investigator.
4 Adequate organ and marrow function, as defined by protocol.
5\. Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.
6\. Histologically confirmed advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC), Gastric or Gastroesophageal junction cancer (G/GEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression.
7\. Participants must have received at least one prior line of systemic therapy in the advanced/metastatic disease.
8\. At least one measurable lesion according to RECIST v1.1.
Exclusion Criteria:
1. Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G/GEJC participants.
2. Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
3. Participants with clinically significant ascites that require drainage.
4. Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.
5. With spinal cord compression or with high risk of paralysis.
6. History of non-infectious interstitial lung disease/pneumonitis.
7. Participant has cardiac abnormalities, as defined by protocol.
8. History of another primary malignancy within 2 years prior to screening.
9. Known serologic status reflecting active hepatitis B or hepatitis C.
10. Known HIV infection that is not well controlled.
11. Active tuberculosis infection.
Where Is This Study? (2 UK sites)
Research Site
Glasgow G12 0YN, United Kingdom
Research Site
London EC1A 7BE, United Kingdom
Data sourced from ClinicalTrials.gov · Last verified: 2026-07