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TerminatedPhase 1NCT06039384
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedINCB099280 and adagrasib

The study team can explain what participation involves.

Who it may be forAdvanced Solid Tumors

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 8, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?14 U.S. locations

Locations may change over time.

Who runs it?Incyte Corporation

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Incyte Corporation
Interventions being studied
Drug: INCB099280; Drug: adagrasib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
Targeted therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • KRASG12C-mutated solid malignancy determined by a sponsor-approved assay using either tumor tissue or ctDNA.
  • Histologically confirmed malignant solid tumor with locally advanced and/or metastatic disease.
  • Only participants with NSCLC will be enrolled into Part 2 Cohort A.
  • Only participants with CRC will be enrolled into Part 2 Cohort B.
  • Part 1: Disease progression on or after at least 1 prior systemic treatment.
  • Part 2 (Cohort A - NSCLC): Received an anti-PD-(L)1-containing regimen and platinum based chemotherapy regimen either concurrently or sequentially
  • Part 2 (Cohort B - CRC): Received at least 1 line of systemic therapy that includes the combination of fluoropyrimidine-based chemotherapy (in combination with oxaliplatin and/or irinotecan) and either a vascular endothelial growth factor-targeting monoclonal antibody or an anti-epidermal growth factor receptor monoclonal antibody (if RAS wild type). Participants with MSI-H/dMMR CRC must also have received a prior immune checkpoint inhibitor approved for this indication.
  • Measurable disease according to RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Estimated life expectancy \> 3 months.
  • Willingness to avoid pregnancy.
Reasons someone may not be able to joinExclusion criteria
  • Known additional malignancy that is progressing or requires active treatment.
  • Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
  • Part 2 only: Prior treatment with an approved or investigational agent targeting KRASG12C.
  • Toxicity from prior therapy that has not recovered to protocol-defined limits.
  • Received thoracic radiation of \> 30 Gy within 6 months of the first dose of study treatment.
  • Participation in another interventional clinical study.
  • History or evidence of interstitial lung disease, including noninfectious pneumonitis.
  • Presence of gastrointestinal condition that may affect drug absorption.
  • Active autoimmune disease requiring systemic treatment, including corticosteroids exceeding a daily dose of 10 mg of prednisone or equivalent.
  • Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy exceeding a daily dose of 10 mg of prednisone or equivalent.
  • Active infection requiring systemic therapy.
  • History of organ transplantation, including allogeneic stem cell transplantation.
  • Receipt of systemic antibiotics within 28 days of the first dose of study treatment.
  • Probiotic usage is prohibited during screening and throughout the study treatment period.
  • Received a live vaccine within 28 days of the planned start of study drug.
  • Laboratory values outside the Protocol-defined ranges. Other protocol-defined Inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Valkyrie Clinical TrialsLos Angeles, California
  • Banner Md Anderson Cancer CenterGreeley, Colorado
  • Henry Ford Health SystemDetroit, Michigan
  • Mary Crowley Cancer Research Centers McCrc HeadquartersDallas, Texas
  • Inova Schar Cancer InstituteFalls Church, Virginia
  • Fondazione Del Piemonte Per L Oncologia Ircc CandioloCandiolo
  • Irccs Istituto Clinico HumanitasRozzano
  • Centro Ricerche Cliniche Di Verona (Crc)Verona
  • Hospital Hm Nou DelfosBarcelona
  • Hospital General Universitario Vall D HebronBarcelona
  • Hospital Universitario Quironsalud MadridPozuelo de Alarcón
  • Hospital Universitario Virgen MacarenaSeville

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 8, 2026. Always confirm current availability with the study team.

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