In short
Clinical trials are investigating Ide397 in people with advanced MTAP-null solid tumors and advanced non-small-cell lung cancer. The studies look at safety, dose, and signs that the treatment may help shrink cancer, especially when Ide397 is used with AMG 193.
Key points
- Clinical trials are studying Ide397 in adults with advanced MTAP-null solid tumors and, in a later part, advanced MTAP-null non-small-cell lung cancer. The study is Phase 1, so its main focus is safety, dose finding, and early signs of anti-cancer activity. Part 1 looks at dose-limiting toxicities, side effects, vital signs, ECGs, and lab tests. Part 2 looks at whether the cancer shrinks or disappears using RECIST v1.1. The trial was completed and enrolled 184 people.
Trial overview
The trial NCT05975073 studied Ide397 together with AMG 193 in adults with advanced MTAP-null solid tumors. The study was titled as a Phase 1/2 study, but the trial record lists the phase as Phase 1.
The study was interventional, which means the researchers gave study treatment and then watched what happened. The trial was completed and enrolled 184 participants.
Who can join the study
In Part 1, the study included adults with locally advanced or metastatic MTAP-null solid tumors. Locally advanced means the cancer has grown beyond its original place, and metastatic means it has spread to other parts of the body.
In Part 2, the study focused on adults with advanced MTAP-null non-small-cell lung cancer (NSCLC). This means the trial moved from a broader solid tumor group to a more specific lung cancer group.
What is being measured
Part 1 mainly checked safety and dose finding, including the maximum tolerated dose, which is the highest dose that people can take safely and still tolerate. It also looked at dose-limiting toxicities, which are side effects that can stop dose increases, and other adverse events that happened after treatment started.
Part 1 also measured changes in vital signs, electrocardiograms, and clinical laboratory tests. These checks help researchers see how the body is handling treatment during the first cycle and after treatment begins.
Part 2 looked at whether the cancer responded to treatment. A response could mean a complete or partial improvement in cancer lesions, which are the visible signs of cancer on scans.
The trial used RECIST v1.1, a standard set of rules for reading tumor scans and deciding whether the cancer is getting better, staying the same, or getting worse.
Study phase and design
This was a Phase 1 study, so the main goal was to learn about safety and dose in people with cancer. Early-phase studies like this are usually done before larger studies that test whether a treatment helps more people.
The study title describes a combination approach with AMG 193 and Ide397, and the brief summary says the research aimed to find the recommended dose and study anti-cancer activity in advanced MTAP-null tumors and NSCLC. In simple terms, the trial asked two main questions: can the treatment be given safely, and does it show signs of helping the cancer?
Results to note from the trial record
The trial record shows that the study was completed. It also shows that 184 people were enrolled, which means they were entered into the study plan.
The available trial data do not provide detailed outcome results in the source record, so this article focuses on the study design, target groups, and endpoints that were measured.