相关临床试验
97
37 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1995
进行中（未招募）
36
37.1%
已完成
29
29.9%
尚未招募
1
1.0%
招募中
18
18.6%
终止
13
13.4%
暂无批准数据
- KRAS, the most frequently mutated oncogene across cancers, was long considered undruggable due to its smooth surface and high-affinity GTP-binding site. - The G12C mutation's cysteine residue enables covalent inhibition, leading to the approval of sotorasib (2021) and adagrasib (2022) in the US. - In CodeBreaK 200, sotorasib improved progression-free survival versus docetaxel (5.6 vs. 4.5 months, HR 0.66) in previously treated KRAS G12C NSCLC. - In colorectal cancer, KRAS G12C inhibition alone shows limited efficacy, requiring combination with anti-EGFR antibodies such as cetuximab or panitumumab.
- The FDA has granted accelerated approval to adagrasib plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer who have received prior chemotherapy. - Efficacy was demonstrated in the KRYSTAL-1 trial, showing a 34% overall response rate and a median duration of response of 5.8 months in heavily pretreated patients. - The most common adverse reactions included rash, nausea, diarrhea, fatigue, and hepatotoxicity, highlighting the importance of monitoring during treatment. - This approval addresses an unmet need in patients with KRAS G12C-mutated CRC who have progressed on standard therapies, offering a new targeted treatment option.
