Whether there are clinical trials of adagrasib (Krazati) in China and introduction to participation conditions

Adagrasib (Krazati) is a KRAS G12C mutation-targeted inhibitor that has received high attention in the international oncology field in recent years. The drug was developed by Mirati Therapeutics and later acquired by Bristol-Myers Squibb (BMS). It has not yet been officially launched in the Chinese market, but it has been authorized to cooperate with Zai Lab (Zai Lab) and is expected to be introduced to China for local clinical research and registration applications in the future. As the clinical value of the KRAS G12C target in lung cancer, colorectal cancer and other fields has been continuously confirmed, the clinical trials of adagrasib in China have also attracted widespread attention.

As of now, China has not publicly disclosed registration clinical trial information for adagrasib, but it has made positive progress in many key studies around the world. For example, KRYSTAL-1, KRYSTAL-12 and other studies have shown that the drug is effective in KRAS Among patients with G12Cmutated non-small cell lung cancer, the objective response rate (ORR) and progression-free survival (PFS) have been significantly improved. These data provide strong support for its future registration application in China and also lay the foundation for local trials.

If clinical trials are launched in China in the future, the conditions for patient participation are expected to be basically consistent with international standards. Generally include: patients with advanced or metastatic solid tumors confirmed to carry KRAS G12C mutations; disease progression after failure of previous standard treatments (such as chemotherapy, immunotherapy); good organ function and physical status (ECOG score usually ≤1); and no serious complications or other clinical trial contraindications. Such inclusion criteria are designed to ensure the accuracy of efficacy assessment and patient safety.

Overall, adagrasib is still in the pre-clinical preparation stage in China, but with its excellent global data and the active promotion of partner companies, it is very likely to start relevant clinical trials in the future. Patients with KRAS G12C mutations who meet the enrollment conditions will have the opportunity to participate and gain early treatment opportunities with innovative targeted drugs. Patients can pay close attention to the National Food and Drug Administration’s clinical trial registration platform and Zai Lab’s announcements to obtain trial recruitment information in a timely manner.

Reference materials:https://www.drugs.com/