Study for AZD4360 in Participants With Advanced Solid Tumours
NCT ID: NCT06921928
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
117 participants
INTERVENTIONAL
2025-04-29
2027-12-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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AZD4360 Monotherapy
AZD4360 Monotherapy
AZD4360
Antibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)
Interventions
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AZD4360
Antibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Santa Monica, California, United States
Research Site
Providence, Rhode Island, United States
Research Site
Houston, Texas, United States
Research Site
Beijing, , China
Research Site
Chengdu, , China
Research Site
Shanghai, , China
Research Site
Wuhan, , China
Research Site
Berlin, , Germany
Research Site
Dresden, , Germany
Research Site
Frankfurt, , Germany
Research Site
Chūōku, , Japan
Research Site
Kashiwa, , Japan
Research Site
Kōtoku, , Japan
Research Site
Glasgow, , United Kingdom
Research Site
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-518281-27-00
Identifier Type: OTHER
Identifier Source: secondary_id
D8930C00001
Identifier Type: -
Identifier Source: org_study_id
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