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About
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.
Enrollment
Sex
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Volunteers
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.
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
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
6 participants in 2 patient groups
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Central trial contact
Incyte Corporation Call Center (ex-US); Incyte Corporation Call Center (US)
Data sourced from clinicaltrials.gov
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