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

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT06039384

Run by

Incyte Corporation

People needed

6

Starts

2023-12-28

Expected to finish

2025-07-11

Last updated by the study team

2025-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Valkyrie Clinical Trials — Los Angeles, California, United States
• Banner Md Anderson Cancer Center — Greeley, Colorado, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Mary Crowley Cancer Research Centers McCrc Headquarters — Dallas, Texas, United States
• Inova Schar Cancer Institute — Falls Church, Virginia, United States
• Fondazione Del Piemonte Per L Oncologia Ircc Candiolo — Candiolo, Italy
• Irccs Istituto Clinico Humanitas — Rozzano, Italy
• Centro Ricerche Cliniche Di Verona (Crc) — Verona, Italy
• Hospital Hm Nou Delfos — Barcelona, Spain
• Hospital General Universitario Vall D Hebron — Barcelona, Spain
• Hospital Universitario Quironsalud Madrid — Pozuelo de Alarcón, Spain
• Hospital Universitario Virgen Macarena — Seville, Spain
• Guys Hospital — London, United Kingdom
• Hammersmith Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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