Study for AZD4360 in Participants With Advanced Solid Tumours

May 19, 2026 updated by: AstraZeneca

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

117

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Research Site
      • Chengdu, China, 610041
        • Recruiting
        • Research Site
      • Shanghai, China, 201318
        • Recruiting
        • Research Site
      • Wuhan, China, 430040
        • Recruiting
        • Research Site
  • Germany
      • Berlin, Germany, 12200
        • Not yet recruiting
        • Research Site
      • Dresden, Germany, 01307
        • Recruiting
        • Research Site
      • Frankfurt, Germany, 60488
        • Recruiting
        • Research Site
  • Japan
      • Chūōku, Japan, 104-0045
        • Recruiting
        • Research Site
      • Kashiwa, Japan, 227-8577
        • Recruiting
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Recruiting
        • Research Site
      • Sendai, Japan, 980-8574
        • Not yet recruiting
        • Research Site
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Recruiting
        • Research Site
      • Leeds, United Kingdom, LS9 7TF
        • Not yet recruiting
        • Research Site
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • Research Site
      • Oxford, United Kingdom, OX3 7LE
        • Not yet recruiting
        • Research Site
  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD4360 Monotherapy
Drug: AZD4360
Antibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of participants with Dose-Limiting Toxicity (in dose escalation cohort), Adverse events (AEs) , Serious Adverse Events (SAEs) and AEs leading to discontinuation of AZD4360
Time Frame: Through study completion, up to approximately 2 years
To investigate the safety and tolerability, and to determine the Maximum Tolerated Dose (MTD) and/or a Recommended Phase II Dose (R2PD) of AZD4360 in previously treated participants with advanced solid tumours, through the assessment of Dose Limiting Toxicities, Adverse Events and Severe Adverse Events.
Through study completion, up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Through study completion, up to approximately 2 years

The percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR).

Radiological response evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Through study completion, up to approximately 2 years
Duration of Response (DoR)
Time Frame: Through study completion, up to approximately 2 years

The time from the date of first documented ORR until date of first documented Progression of Disease (PD) or death.

Radiological response evaluated according to RECIST v1.1.
Through study completion, up to approximately 2 years
Disease Control Rate (DCR)
Time Frame: Through study completion, up to approximately 2 years

The percentage of participants who have a best objective response of confirmed CR or PR or who have Stable Disease for at least 11 weeks after start of treatment to allow for an early assessment within the assessment window.

Radiological response evaluated according to RECIST v1.1.
Through study completion, up to approximately 2 years
Progression Free Survival (PFS)
Time Frame: Through study completion, up to approximately 2 years

The time from the start of treatment until the date of objective PD or death.

Radiological response evaluated according to RECIST v1.1.
Through study completion, up to approximately 2 years
Overall Survival (OS)
Time Frame: Through study completion, up to approximately 2 years
The time from the start of treatment until death due to any cause.
Through study completion, up to approximately 2 years
Plasma pharmacokinetics (PK) parameters of AZD4360: Plasma concentration
Time Frame: Through study completion, up to approximately 2 years
Plasma concentration of AZD4360, total antibody and other analytes.
Through study completion, up to approximately 2 years
Plamsa PK parameters of AZD4360, total antibody and other analytes: Area Under Curve (AUC)
Time Frame: Through study completion, up to approximately 2 years
Area under the plasma concentration versus time curve for AZD4360, total antibody and other analytes.
Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Maximum plasma concentration (Cmax)
Time Frame: Through study completion, up to approximately 2 years
Maximum observed plasma concentration of AZD4360, total antibody and other analytes.
Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Time to maximum plasma concentration (tmax)
Time Frame: Through study completion, up to approximately 2 years
The time it takes for AZD4360, total antibody and other analytes to reach the maximum plasma concentration after administration of the study drug.
Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Clearance
Time Frame: Through study completion, up to approximately 2 years
A pharmacokinetic measurement of the volume of plasma from which AZD4360, total antibody and other analytes are completely removed per unit time.
Through study completion, up to approximately 2 years
Plasma PK parameters of AZD4360, total antibody and other analytes: Half-life
Time Frame: Through study completion, up to approximately 2 years
The time required for the quantity of AZD4360, total antibody and other analytes to reduce to half of their initial values.
Through study completion, up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 16, 2027

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8930C00001
  • 2024-518281-27-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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