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2023-07-11
2026-12-16
2026-12-16
240
NCT06005493
AstraZeneca
AstraZeneca
INTERVENTIONAL
Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors
This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.
This is a first-time in human, modular Phase I/II, open-label multicentre study of AZD5863 monotherapy administered intravenously (Module 1), or AZD5863 monotherapy administered subcutaneously (Module 2) in patients with advanced or metastatic solid tumors. Each module contains dose-escalation (Part A) and dose-expansion (Part B).
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 |
|---|---|---|
2023-06-16 | N/A | 2025-06-24 |
2023-08-17 | N/A | 2025-06-25 |
2023-08-22 | N/A | 2025-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Module 1: AZD5863 Monotherapy Intravenous (IV) Module 1: AZD5863 Intravenous (IV) Monotherapy | DRUG: AZD5863
|
| EXPERIMENTAL: Module 2: AZD5863 Monotherapy Subcutaneous (SC) Module 2: AZD5863 Subcutaneous (SC) Monotherapy | DRUG: AZD5863
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| The number of patients with adverse events | Number of patients with adverse events by system organ class and preferred term | From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy |
| The number of patients with adverse events of special interest | Number of patients with adverse events of special interest by system organ class and preferred term | From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy |
| The number of patients with dose-limiting toxicity (DLT), as defined in the protocol. | A DLT is a toxicity as defined in the protocol that occurs from the first dose of study drug up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation. | From first dose of study drug until the end of Cycle 1 |
| The number of patients with serious adverse events | Number of patients with serious adverse events by system organ class and preferred term | From first dose of study drug up to 90 days post last dose and prior to start of subsequent anticancer therapy |
| Objective Response Rate (ORR) | The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1). Dose expansion only. | From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The percentage of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours (RECIST 1.1). Dose escalation only. | From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years) |
| Disease Control Rate (DCR) | Percentage of patients with confirmed complete or partial response or having stable disease maintained for >= 11 weeks from first dose, according to response criteria in solid tumours (RECIST 1.1). | From first dose of study drug to progressive disease or death in the absence of disease progression (approx. 2 years) |
| Duration of response (DoR) | The time from the date of first response until date of disease progression or death in the absence of disease progression, according to response criteria in solid tumours (RECIST 1.1). | From the first documented response to progressive disease or death in the absence of disease progression (approx. 2 years) |
| Progression free Survival (PFS) | The time from the start of study treatment/date of randomization until RECIST 1.1 defined disease progression or death in the absence of disease progression. | From the start of study treatment/date of randomization to progressive disease or death in the absence of disease progression (approx. 2 years) |
| Overall Survival (OS) | The time from the start of study treatment/date of randomization until death due to any cause. | From the start of study treatment/date of randomization to death (to be followed-up for approx. 2 years) |
| Pharmacokinetics of AZD5863: Maximum plasma concentration of the study drug (Cmax) | Maximum observed plasma concentration of the study drug | From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years) |
| Pharmacokinetics of AZD5863: Area Under the concentration-time curve (AUC) | Area under the plasma concentration-time curve | From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years) |
| Pharmacokinetics of AZD5863: Clearance | A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time. | From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years) |
| Pharmacokinetics of AZD5863: Terminal elimination half-life (t 1/2) | Terminal elimination half life. | From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years) |
| Immunogenicity of AZD5863 | The number and percentage of participants who develop anti-drug antibodies (ADAs) measured in serum | From the first dose of study intervention, at predefined intervals throughout the study (approx. 2 years) |
| Preliminary antitumor activity with target expression pre- and post-delivery of AZD5863 | Measure CLDN18.2 expression (IHC) in baseline and/or on-treatment tumor biopsies and correlate with clinical outcome | From time of Informed consent, at predefined intervals (including screening, on-treatment or end of treatment) throughout the study (over approx. 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
