Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 130Years
All Genders
NCT06921928

Study for AZD4360 in Participants With Advanced Solid Tumours

Led by AstraZeneca · Updated on 2026-04-23

117

Participants Needed

18

Research Sites

137 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Study for AZD4360 in Participants With Advanced Solid Tumours

Who Can Participate

Age: 18Years - 130Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 18 years or older at time of consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 without recent deterioration
  • Minimum life expectancy of 12 weeks as judged by investigator
  • Adequate organ and marrow function per protocol definitions
  • Use of contraception consistent with local regulations
  • Histologically confirmed advanced or metastatic pancreatic ductal adenocarcinoma, gastric or gastroesophageal junction cancer, or biliary tract cancer with positive CLDN18.2 expression
  • Received at least one prior line of systemic therapy for advanced/metastatic disease
  • At least one measurable lesion according to RECIST v1.1
Not Eligible

You will not qualify if you...

  • HER2 positive or indeterminate status in gastric or gastroesophageal junction cancer
  • Unstable or active peptic ulcer disease or digestive tract bleeding, including significant bleeding related to prior CLDN18.2 therapy
  • Clinically significant ascites requiring drainage
  • Central nervous system metastases or pathology
  • Spinal cord compression or high risk of paralysis
  • History of non-infectious interstitial lung disease or pneumonitis
  • Cardiac abnormalities as defined by protocol
  • History of another primary malignancy within 2 years prior to screening
  • Active hepatitis B or hepatitis C infection
  • HIV infection that is not well controlled
  • Active tuberculosis infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

Research Site

Santa Monica, California, United States, 90404

Actively Recruiting

2

Research Site

Providence, Rhode Island, United States, 02903

Actively Recruiting

3

Research Site

Houston, Texas, United States, 77030

Actively Recruiting

4

Research Site

Beijing, China, 100730

Actively Recruiting

5

Research Site

Chengdu, China, 610041

Actively Recruiting

6

Research Site

Shanghai, China, 201318

Actively Recruiting

7

Research Site

Wuhan, China, 430040

Actively Recruiting

8

Research Site

Berlin, Germany, 12200

Not Yet Recruiting

9

Research Site

Dresden, Germany, 01307

Actively Recruiting

10

Research Site

Frankfurt, Germany, 60488

Actively Recruiting

11

Research Site

Chūōku, Japan, 104-0045

Actively Recruiting

12

Research Site

Kashiwa, Japan, 227-8577

Actively Recruiting

13

Research Site

Kōtoku, Japan, 135-8550

Actively Recruiting

14

Research Site

Sendai, Japan, 980-8574

Not Yet Recruiting

15

Research Site

Glasgow, United Kingdom, G12 0YN

Not Yet Recruiting

16

Research Site

Leeds, United Kingdom, LS9 7TF

Not Yet Recruiting

17

Research Site

London, United Kingdom, EC1A 7BE

Actively Recruiting

18

Research Site

Oxford, United Kingdom, OX3 7LE

Not Yet Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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