Can a drug duo outsmart a common cancer mutation?

NCT ID NCT06039384

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This early-stage trial tests whether combining two drugs, INCB099280 and adagrasib, is safe and tolerable for adults with advanced solid tumors that carry a specific genetic change called KRAS G12C. The study enrolls people whose cancer has spread or is locally advanced and who have already tried at least one prior treatment. Researchers aim to find the right dose and watch for side effects, while also measuring how the drugs behave in the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INCB099280 combined with adagrasib (KRAZATI)
What this could lead to
If the combination proves safe and tolerable, it could lead to a new treatment option for advanced cancers with the KRAS G12C mutation.
What could go wrong
This is an early, small phase 1 trial focused on safety and dosing, so it may not lead to an approved treatment. The combination may cause side effects or fail to show enough benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

6 people

The number who actually took part.

Started

Dec 2023

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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. Exclusion 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/Exclusion Criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Banner Md Anderson Cancer Center

    Greeley, Colorado, 80631, United States

  • Centro Ricerche Cliniche Di Verona (Crc)

    Verona, 37124, Italy

  • Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

    Candiolo, 10060, Italy

  • Guys Hospital

    London, SE1 9RT, United Kingdom

  • Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hospital General Universitario Vall D Hebron

    Barcelona, 08035, Spain

  • Hospital Hm Nou Delfos

    Barcelona, 08023, Spain

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Inova Schar Cancer Institute

    Falls Church, Virginia, 22042, United States

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Mary Crowley Cancer Research Centers McCrc Headquarters

    Dallas, Texas, 75251, United States

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067, United States

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