A trial to learn how safe AZD4360 is, how well it works, and how it moves throughout the body over time in adults with advanced solid tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

9 Jan 2026 → ongoing

Decision date (initial)

2025-09-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AstraZeneca AB

External identifiers

EU CT number

2024-518281-27-00

ClinicalTrials.gov

NCT06921928

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To investigate the safety and tolerability, and to determine the Maximum Tolerated Dose and/or a Recommended Phase 2 Dose of AZD4360 in previously treated participants with advanced solid tumours with CLDN18.2 expression.

Secondary objectives 3

1. To evaluate the preliminary efficacy of AZD4360 in previously treated participants with advanced solid tumours with CLDN18.2 expression.
2. To characterise the PK of AZD4360 in previously treated participants with advanced solid tumours with CLDN18.2 expression.
3. To determine the immunogenicity of AZD4360.

Conditions and MedDRA coding

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

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

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 RECISTv1.1.

Exclusion criteria 11

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Frequency of DLTs (dose escalation cohort)
2. Incidence of AEs, SAEs, and AEs leading to discontinuation of AZD4360
3. Assess clinically significant changes in vital signs, laboratory parameters, and ECG results

Secondary endpoints 5

1. Radiological response evaluated according to RECISTv1.1: Overall Response Rate, Duration of Response,Disease Control Rate, and Progression-free Survival
2. Overall Survival
3. Pharmamokinetics end points: Plasma concentration of AZD4360 total antibody and other analytes
4. Plasma PK parameters of AZD4360, total antibody andother analytes including but not limited to AUC, Cmax, tmax, clearance, and half-life, as data allow
5. Immunogenecitiy end point: Number and percentage of participants who develop ADA against AZD4360

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications