A Phase 1 Study of INCB099280 With Adagrasib in Advanced Solid Tumors
A Phase 1 Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation
This research study will test how safe investigational medicinal product, INCB099280, is when taken in combination with another investigational medicinal product called adagrasib to determine how well it is tolerated and to find out what other effects, if any, this Investigational Combination has on people and their cancer. This Study will also test different doses of the Investigational Combination to see which dose is safer or may work better in participants as well as analyse the ways in which INCB099280 is broken down in the body and eliminated.
The study will consist of two parts. During part 1 ~45 participants with solid tumours who have abnormal KRASG12C genetic mutation will be evaluated for safety of the investigational combination and how they and their disease react to it as well as determining the highest dose with fewest side effects (Dose Escalation). Some participants in part 1 will receive a single therapy treatment with INCB099280 for 8 days prior to investigational combination (lead-in) to allow evaluation and comparison of study drug in the blood with and without adagrasib. In part 2, ~80 participants with KRASG12C mutated lung cancer and/or colorectal cancer will be enrolled in up to three dose level combinations to further investigate the safety and impact of the combination on cancer (Dose Expansion).
INCB099280 can be administered for up to 2 years. Safety follow up will last from 30 (+7) to 90 (+14) days post last dose. It is estimated that an individual will participate for ~9 months.
East of England - Essex Research Ethics Committee
Date of REC Opinion
26 Oct 2023
Further Information Favourable Opinion