Table of contents
- Trial overview
- Who can participate
- Study design and phases
- What the study is measuring
- Trial status and size
- What these terms mean for patients
Trial overview
This study is a Phase 1/2 trial of Azd5863 in adult participants with advanced or metastatic solid tumors.[1] The study is authorised and is designed to look at both safety and early signs of antitumor activity.[1]
The trial is focused on tumors with CLDN18.2 expression, which means the cancer cells have a specific marker the study is looking for.[1] Azd5863 is being studied as monotherapy, which means used by itself, or in combination with other treatment.[1]
Who can participate
The trial is for adult participants with advanced or metastatic solid tumors.[1] The study summary also says the tumors must express CLDN18.2.[1]
Because this is an early clinical trial, people who join are usually closely monitored for side effects, lab changes, and other health changes during treatment.[1]
Study design and phases
The trial has two main parts: dose escalation and dose expansion.[1] Dose escalation is the part where researchers study different dose levels to help find the safest and most useful dose range.[1]
In dose escalation, the study aims to investigate safety and tolerability, describe dose-limiting toxicities, and determine the maximum tolerated dose and/or recommended phase 2 dose.[1] Maximum tolerated dose means the highest dose people can take without too many serious side effects, and recommended phase 2 dose means the dose chosen for later study.[1]
In dose expansion, more participants are treated at selected dose levels to learn more about safety and early antitumor activity.[1]
What the study is measuring
The main outcomes in dose escalation include the number of adverse events, adverse events of special interest, dose-limiting toxicities, and serious adverse events.[1] Adverse events are any unwanted medical problems during the study, while serious adverse events are more severe problems.[1]
Researchers also check for adverse events that lead to stopping Azd5863, and for clinically significant changes in vital signs and abnormal laboratory values.[1] Vital signs include measures like blood pressure and pulse, and laboratory values are blood test results.[1]
In dose expansion, the study again tracks adverse events, serious adverse events, and treatment stopping because of side effects.[1] It also measures objective response rate using RECIST v1.1, which shows how many tumors shrink or disappear on scans.[1]
The brief summary says the study also aims to evaluate preliminary antitumor activity, which means early evidence that the treatment may help fight the cancer.[1]
Trial status and size
The trial status is Authorised.[1] The planned enrollment is 272 participants.[1]
This size suggests the study is large enough to collect early safety data and to look for signals of activity in the target cancer group.[1]
What these terms mean for patients
Advanced cancer means the disease is more serious or has grown beyond an early stage.[1] Metastatic cancer means it has spread to other parts of the body.[1]
Monotherapy means one treatment is used alone, while combination treatment means it is given with another therapy.[1] Clinical trials like this one are done in steps so researchers can learn if the treatment is safe enough and whether it may help patients.[1]
