In short
Clinical trials are investigating Azd5863 in adults with advanced or metastatic solid tumors, including tumors with CLDN18.2 expression. These studies are looking at safety, tolerability, dose finding, and early signs of antitumor activity in phase 1/2 research.
Key points
- Azd5863 is being studied in a Phase 1/2 clinical trial in adults with advanced or metastatic solid tumors. The study includes tumors with CLDN18.2 expression, so it focuses on a specific patient group. Researchers are testing Azd5863 alone or in combination to learn about safety, tolerability, and the right dose. The trial also looks for early signs that the treatment may shrink tumors. Main results include side effects, serious side effects, dose-limiting toxicities, and objective response rate.
Trial overview
This study is a Phase 1/2 trial of Azd5863 in adult participants with advanced or metastatic solid tumors. The study is authorised and is designed to look at both safety and early signs of antitumor activity.
The trial is focused on tumors with CLDN18.2 expression, which means the cancer cells have a specific marker the study is looking for. Azd5863 is being studied as monotherapy, which means used by itself, or in combination with other treatment.
Who can participate
The trial is for adult participants with advanced or metastatic solid tumors. The study summary also says the tumors must express CLDN18.2.
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.
Study design and phases
The trial has two main parts: dose escalation and dose expansion. Dose escalation is the part where researchers study different dose levels to help find the safest and most useful dose range.
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. 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.
In dose expansion, more participants are treated at selected dose levels to learn more about safety and early antitumor activity.
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. Adverse events are any unwanted medical problems during the study, while serious adverse events are more severe problems.
Researchers also check for adverse events that lead to stopping Azd5863, and for clinically significant changes in vital signs and abnormal laboratory values. Vital signs include measures like blood pressure and pulse, and laboratory values are blood test results.
In dose expansion, the study again tracks adverse events, serious adverse events, and treatment stopping because of side effects. It also measures objective response rate using RECIST v1.1, which shows how many tumors shrink or disappear on scans.
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.
Trial status and size
The trial status is Authorised. The planned enrollment is 272 participants.
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.
What these terms mean for patients
Advanced cancer means the disease is more serious or has grown beyond an early stage. Metastatic cancer means it has spread to other parts of the body.
Monotherapy means one treatment is used alone, while combination treatment means it is given with another therapy. 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.