A Phase 1 Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation
NCT #
NCT06039384
Condition(s)
Colorectal Cancer, Lung Cancer (NSCLC), Solid Tumor
Molecular Target(s)
KRAS G12, KRAS G12C, KRAS MUTATION, PD-L1
Drug Classification(s)
Small Molecule Immunotherapy
Agents(s)
INCB099280
Phase(s)
I
Mechanism of Action
INCB099280 is a PD-L1 inhibitor. Adagrasib is a KRAS inhibitor (G12C).
Purpose
- How much of the study s can be given with an acceptable level of side effects
- The effects of the study s (good and bad)
- How much of the study s are absorbed into the blood and how fast they are removed
- How the study s are acting on your body
- 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.
- 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.
No restrictions
Location
MCD
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