Table of contents
- Trial overview
- Who can join the study
- What is being measured
- Study phase and design
- Results to note from the trial record
Trial overview
The trial NCT05975073 studied Ide397 together with AMG 193 in adults with advanced MTAP-null solid tumors.[1] The study was titled as a Phase 1/2 study, but the trial record lists the phase as Phase 1.[1]
The study was interventional, which means the researchers gave study treatment and then watched what happened.[1] The trial was completed and enrolled 184 participants.[1]
Who can join the study
In Part 1, the study included adults with locally advanced or metastatic MTAP-null solid tumors.[1] Locally advanced means the cancer has grown beyond its original place, and metastatic means it has spread to other parts of the body.[1]
In Part 2, the study focused on adults with advanced MTAP-null non-small-cell lung cancer (NSCLC).[1] This means the trial moved from a broader solid tumor group to a more specific lung cancer group.[1]
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.[1] 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.[1]
Part 1 also measured changes in vital signs, electrocardiograms, and clinical laboratory tests.[1] These checks help researchers see how the body is handling treatment during the first cycle and after treatment begins.[1]
Part 2 looked at whether the cancer responded to treatment.[1] A response could mean a complete or partial improvement in cancer lesions, which are the visible signs of cancer on scans.[1]
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.[1]
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.[1] Early-phase studies like this are usually done before larger studies that test whether a treatment helps more people.[1]
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.[1] In simple terms, the trial asked two main questions: can the treatment be given safely, and does it show signs of helping the cancer?[1]
Results to note from the trial record
The trial record shows that the study was completed.[1] It also shows that 184 people were enrolled, which means they were entered into the study plan.[1]
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.[1]
