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Clinical Trials in the USA / NCT06921928
Active, not recruiting Phase 1/2

Study for AZD4360 in Participants With Advanced Solid Tumours

NCT06921928 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 1/2
Started
2025-04-29
Last updated
2026-07-31

Condition(s) studied

Gastric CancerGastroesophageal Junction CancerBiliary Tract CancerPancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

AZD4360

AZD4360: Antibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Research Site Santa Monica California
Research Site Providence Rhode Island
Research Site Houston Texas
Research Site Beijing China
Research Site Chengdu China
Research Site Shanghai China
Research Site Wuhan China
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06921928 on ClinicalTrials.gov ↗ ← All trials in the USA