Table 2.
Reported clinical trials of KRAS G12C inhibitors in metastatic colorectal cancer
| Trial name | Phase | drug | Tumor type | Number of patients | Regimen | ORR (%) | DCR (%) | Median PFS (months) | Median overall survival (months) |
|---|---|---|---|---|---|---|---|---|---|
| CodeBreaK 300, (NCT05198934) | III | sotorasib | advanced CRC with KRAS G12C mutation |
53patients 53patients 54patients |
Sotorasib (960 mg,po,qd) plus panitumumab, Sotorasib (240 mg,po,qd) plus panitumumab, the investigator’s choice of trifluridine-tipiracil or regorafenib |
26.4%; 5.7% 0% |
5.6 m (4.2–6.3) ; 3.9 m (3.7–5.8) ; 2.2 m (1.9–3.9) |
maturing | |
| CodeBreaK 101(NCT04185883) | 1b | sotorasib | advanced mCRC with KRAS G12C mutation | 48 | Sotorasib (960 mg,po,qd) combine with panitumunab(6 mg/kg.iv.q2w) standard FOLFIRI(iv,q2w) | 58.1% | 93.5% | 5.7 m | 15.2 m |
| CodeBreaK100 (NCT03600883) | I/II | sotorasib | advanced mCRC with KRAS G12C mutation | 62 | Soto (960 mg,po,qd) | 9.7% | 82.3% | 4.0 m | 10.6 m |
| NCT03785249 | I/IB | Adagrasib | advanced CRC with KRAS G12C mutation |
44 pts ada 32 pts ada + cetux. |
Adagrasib (600 mg BID) in combination with/notwith intravenous cetuximab (cetux:400 mg/m2 followed by 250 mg/m2 QW or 500 mg/m2 Q2W) |
19% 46% |
86% 100% |
5.6 m 6.9 m |
|
| NCT04585035 | II | D-1553 (Garsorasib) | mCRC with KRAS G12C mutation | 40 | Garsorasib (600 mg BlD) plus Cetuximab (standard dose) | 45.0% | 95% | 7.62 m | maturing |
| NCT05497336 | 1b | IBI351 (GFH925) | advanced m CRC with KRAS G12C mutation | 42 | 600 mg BID | 43.5% | 87% | ||
| Codebreak300 (NCT05194995) | I/II | JAB-21822+Cetuximab | advanced CRC, small intestine cancer and appendiceal cancer with KRAS G12C mutation | 160 | JAB 21822+Cetuximab | 26.4% | 72% | 5.6 m |