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Only for patients with KRASG12C-mutated solid malignancy, like colon or rectal KRAS G12C mutant cancer. Both MSS and MSI-H are included.
For MSI-H patients, prior anti PD-1/PD-L1 is *required* (is not only allowed but it is required that they have received prior immunotherapy).
INCB099280 in combination with adagrasib. Both are ORAL agents.

INCB099280: checkpoint inhibitor, anti PD-L1. Oral immunotherapy. Other approved anti PD-L1 inhibitors –atezolizumab (Tecentriq), avelumab (Bavencio), durvalumab (Imfinzi)– are intravenous.

adagrasib: KRAS G12C inhibitor, Krazati®. Oral.

Check updated locations at https://classic.clinicaltrials.gov/ct2/show/NCT06039384#contacts

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Inclusion Criteria

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

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.