A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation
Reason given: This was a strategic business decision. There were no safety concerns contributing to this decision.
Key facts
- Where
- Dallas, Detroit, Falls Church, Greeley, and Los Angeles, United StatesSee the 5 sites
- Phase
- Phase 1
Where in United States
- Mary Crowley Cancer Research Centers McCrc HeadquartersDallas, United StatesNo longer taking part
- Henry Ford Health SystemDetroit, United StatesNo longer taking part
- Inova Schar Cancer InstituteFalls Church, United StatesNo longer taking part
- Banner MD Anderson Cancer CenterGreeley, United StatesNo longer taking part
- Valkyrie Clinical TrialsLos Angeles, United StatesNo longer taking part
Trial details
- Who runs it
- Incyte Corporation
- Trial code
- NCT06039384EU 2023-503223-26-00
- Record updated
- 8 September 2026
- Original description
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.Read full original descriptionShow less
A Phase 1 Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation
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.
Inclusion: 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: 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; Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy exceeding a daily dose of 10 mg of prednisone or equivalent; Received a live vaccine within 28 days of the planned start of study drug; Known additional malignancy that is progressing or requires active treatment; Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease; 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; Active infection requiring systemic therapy; History of organ transplantation, including allogeneic stem cell transplantation; Laboratory values outside the Protocol-defined ranges; Other protocol-defined Inclusion/Exclusion Criteria may apply; Participation in another interventional clinical study; 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.