NCT06921928

Study for AZD4360 in Participants With Advanced Solid Tumours

A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD4360 in Adult Participants With Advanced Solid Tumours

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 117 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer
• Gastroesophageal Junction Cancer
• Biliary Tract Cancer
• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	AZD4360	Antibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)

Timeline

• Start date: 2025-04-29
• Primary completion: 2027-03-31
• Completion: 2027-12-16
• First posted: 2025-04-10
• Last updated: 2026-03-17

Locations

17 sites across 5 countries: United States, China, Germany, Japan, United Kingdom

Regulatory

• FDA-regulated drug study