Adagrasib / Advanced Solid Tumors / INCB099280 · Phase 1 Trial

A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation

ClinicalTrials.gov · September 8, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 combination safety study that was terminated early after enrolling only 6 participants. No efficacy or safety results are reported in this registry record, and the small enrollment prevents any reliable characterization of the toxicity profile or maximum tolerated dose.

What was studied

Phase 1, Interventional, Randomized, Sequential, Open label, Treatment purpose. Advanced Solid Tumors; age from 18 Years. Intervention: Part 1: Dose Finding; Part 2: Dose Expansion. n = 6. 14 sites across 4 countries.

Key findings

Safety

No efficacy outcomes measured; safety and tolerability endpoints not reported here.

Who this may help

This terminated early-phase study provides no actionable clinical evidence. Clinicians should not interpret this as evidence for or against the combination and should await full publication of results, if any, or subsequent trials with adequate enrollment.

Plain-language summary

Phase 1 dose-escalation study of a novel combination in advanced solid tumors, terminated after enrolling only 6 participants; no results are posted in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Number of Participants With Dose-limiting Toxicities (DLTs) (assessed at up to Day 28); Number of Participants With Treatment-emergent Adverse Events (TEAEs) (assessed at up to 574 days); Number of Participants With TEAEs Leading to Treatment Interruptions, Dose Reductions, and Permanent Discontinuation of INCB099280 and Adagarsib (assessed at up to 574 days)

DesignPhase 1, Interventional, Randomized, Sequential, Open label, Treatment purpose

PopulationAdvanced Solid Tumors; age from 18 Years

Sample size6

InterventionPart 1: Dose Finding; Part 2: Dose Expansion

Setting14 sites across 4 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment6

Recruitment statusTERMINATED

PhasePHASE 1

Primary outcome: DLTsNumber of Participants With Dose-limiting Toxicities, up to Day 28

Primary outcome: TEAEsNumber of Participants With Treatment-emergent Adverse Events, up to 574 days

Primary outcome: Treatment discontinuationsNumber of Participants With TEAEs Leading to Treatment Interruptions, Dose Reductions, and Permanent Discontinuation, up to 574 days

Clinical bottom line

Caveats

Study terminated early after only 6 participants; no results posted in registry record.
No efficacy outcomes measured; safety and tolerability endpoints not reported here.
No maximum tolerated dose or recommended dose established based on the enrolled cohort.
Geography, specific enrollment dates, and detailed methods not stated in registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1 interventional design appropriate for safety; standard dose escalation approach.

Directness

limited

Safety and tolerability outcomes are surrogate measures, not clinical efficacy endpoints.

Consistency

insufficient

Single-arm, first-in-human combination; no comparator or replicate data available.

Risk of bias

moderate

Phase 1 design inherently unblinded; small size and early termination limit interpretability.

Sample adequacy

insufficient

Only 6 participants enrolled before termination; vastly underpowered for safety or MTD determination.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06039384). This is a study registration, not published results. Lead sponsor: Incyte Corporation. Recruitment status: TERMINATED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 6 participants (ACTUAL). Conditions: Advanced Solid Tumors. Interventions: DRUG: INCB099280; DRUG: adagrasib. Primary outcome measures: Number of Participants With Dose-limiting Toxicities (DLTs) , up to Day 28; Number of Participants With Treatment-emergent Adverse Events (TEAEs) , up to 574 days; Number of Participants With TEAEs Leading to Treatment Interruptions, Dose Reductions, and Permanent Discontinuation of INCB099280 and Adagarsib , up to 574 days. Brief summary: The purpose of this study is to evaluate the safety and tolerability of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT06039384AdagrasibAdvanced Solid TumorsIncyteINCB099280