Adagrasib Combination Trial Results Posted in Solid Tumors

ClinicalTrials.gov posted results on 8 September 2026 for a terminated Phase 1 study of adagrasib combined with INCB099280 in adults with advanced solid tumors harboring a KRASG12C mutation. The study enrolled 6 participants; reported dose-limiting toxicities occurred in 0 participants in one combination group and 1 participant in the other.

Background

The study evaluated INCB099280 in combination with adagrasib in adults with advanced solid tumors harboring a KRASG12C mutation. Its stated purpose was to assess the safety and tolerability of the combination and establish the maximum tolerated dose or recommended dose expansion dose. The listed interventions were INCB099280 and adagrasib.

Trial design

This Phase 1 study, identified as NCT06039384, enrolled 6 participants with advanced solid tumors. The trial record lists two combination groups: INCB099280 50 mg once daily plus adagrasib 400 mg twice daily, and INCB099280 100 mg twice daily plus adagrasib 400 mg twice daily. The overall study status was terminated. No primary-outcome entries were supplied in the data.

Key results

For dose-limiting toxicities, the 50-mg once-daily INCB099280 group plus adagrasib had 0 participants with a DLT, while the 100-mg twice-daily INCB099280 group plus adagrasib had 1 participant with a DLT. Treatment-emergent adverse events were reported in 3 participants in each group.

The record also listed treatment-emergent adverse events leading to treatment interruptions, dose reductions, or permanent discontinuation. The reported counts were 2 participants in the 50-mg once-daily group and 0 participants in the 100-mg twice-daily group. Additional entries under the same outcome title reported counts of 0 participants in both groups and, in another entry, 2 participants in the lower-dose group and 0 participants in the higher-dose group.

What this means

The posted results provide safety and tolerability measurements from a small, terminated Phase 1 study of adagrasib with INCB099280. The data show one reported DLT in the higher INCB099280 dose group and treatment-emergent adverse events in three participants in each group. The supplied record did not include efficacy outcomes, p-values, confidence intervals, or an adverse-event summary.

Source

Source: ClinicalTrials.gov, registry results for the Phase 1 study of INCB099280 combined with adagrasib in adults with advanced solid tumors harboring a KRASG12C mutation, posted 8 September 2026. Available at clinicaltrials.gov/study/NCT06039384.