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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518281-27-00 | Other Identifier | EU CT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD4360 Monotherapy | Experimental | AZD4360 Monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4360 | Drug | Antibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2) |
|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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) |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Santa Monica | California | 90404 | United States | |
| Research Site |
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.
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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.
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.
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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) | 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) | 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) | 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 | 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) | 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) | 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) | 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 | 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 | 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 |
| Recruiting |
| Providence |
| Rhode Island |
| 02903 |
| United States |
| Research Site | Recruiting | Houston | Texas | 77030 | United States |
| Research Site | Recruiting | Beijing | 100730 | China |
| Research Site | Recruiting | Chengdu | 610041 | China |
| Research Site | Recruiting | Shanghai | 201318 | China |
| Research Site | Recruiting | Wuhan | 430040 | China |
| Research Site | Not yet recruiting | Berlin | 12200 | Germany |
| Research Site | Recruiting | Dresden | 01307 | Germany |
| Research Site | Recruiting | Frankfurt | 60488 | Germany |
| Research Site | Recruiting | Chūōku | 104-0045 | Japan |
| Research Site | Recruiting | Kashiwa | 227-8577 | Japan |
| Research Site | Recruiting | Kōtoku | 135-8550 | Japan |
| Research Site | Not yet recruiting | Sendai | 980-8574 | Japan |
| Research Site | Recruiting | Glasgow | G12 0YN | United Kingdom |
| Research Site | Not yet recruiting | Leeds | LS9 7TF | United Kingdom |
| Research Site | Recruiting | London | EC1A 7BE | United Kingdom |
| Research Site | Not yet recruiting | Oxford | OX3 7LE | United Kingdom |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D001660 | Biliary Tract Diseases |
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