Can a drug duo outsmart a common cancer mutation?
NCT ID NCT06039384
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Jul 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Banner Md Anderson Cancer Center
Greeley, Colorado, 80631, United States
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Centro Ricerche Cliniche Di Verona (Crc)
Verona, 37124, Italy
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Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
Candiolo, 10060, Italy
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Guys Hospital
London, SE1 9RT, United Kingdom
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Hammersmith Hospital
London, W12 0HS, United Kingdom
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Henry Ford Health System
Detroit, Michigan, 48202, United States
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Hospital General Universitario Vall D Hebron
Barcelona, 08035, Spain
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Hospital Hm Nou Delfos
Barcelona, 08023, Spain
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Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, 28223, Spain
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Hospital Universitario Virgen Macarena
Seville, 41009, Spain
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Inova Schar Cancer Institute
Falls Church, Virginia, 22042, United States
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Irccs Istituto Clinico Humanitas
Rozzano, 20089, Italy
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Mary Crowley Cancer Research Centers McCrc Headquarters
Dallas, Texas, 75251, United States
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Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
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