2025-05-23
2027-07-31
2027-12-14
117
NCT06921928
AstraZeneca
AstraZeneca
INTERVENTIONAL
Study for AZD4360 in 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.
N/A
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-03-25 | N/A | 2025-04-03 |
2025-04-03 | N/A | 2025-04-10 |
2025-04-10 | N/A | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: AZD4360 Monotherapy AZD4360 Monotherapy | DRUG: AZD4360
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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) | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: AstraZeneca Clinical Study Information Center Phone Number: 1-877-240-9479 Email: information.center@astrazeneca.com |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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