In this phase 2, single-arm trial the safety and efficacy of tepotinib, an oral once-daily MET inhibitor, will be investigated in combination with cetuximab in patients with RAS/BRAF wild-type, left-sided mCRC and acquired resistance to prior anti-EGFR monoclonal antibody therapy due to MET amplification
The primary outcomes of the trial are:
The trial will also measure:
*For a full list of all outcome measures and inclusion and exclusion criteria, please visit ClinicalTrials.gov NCT04515394.
†Patients must have had a radiologically confirmed response (for at least 4 months) or stable disease (for a least 6 months) to treatment with previous anti-EGFR antibody therapy, followed by radiologically documented disease progression. Radiological assessments must be made according to RECIST v1.1.
§500 mg tepotinib hydrochloride hydrate which is equivalent to 450 mg tepotinib (the free base form).
¶Treatment continues until progression of disease, death, withdrawal of consent, or development of unacceptable toxicities.
§Patients will receive an initial dose of tepotinib, 500 mg QD (450 mg active moiety), combined with an initial dose of cetuximab 400 mg/m² (unless cetuximab was given as prior line therapy), followed by a continuous dose of tepotinib (500 mg QD) combined with cetuximab 250 mg/m² once weekly. If 500 mg QD of tepotinib is not tolerated, the continuous dose should be reduced to 250 mg QD with 250 mg/m² of cetuximab once weekly.
DC, disease control; DLT, dose-limiting toxicity; DOR, duration of response; OR, objective response; OS, overall survival; PFS, progression-free survival; QD, once daily; RP2D, recommended phase 2 dose.
Tepotinib is being investigated in this clinical trial and is under clinical investigation in several countries. This page describes one of the clinical trials for tepotinib, and it includes information about how the safety and efficacy of tepotinib will be measured and evaluated. The safety and efficacy of tepotinib have to be investigated following the respective local regulations and laws. There is no guarantee that tepotinib will be approved in the sought-after indication by the competent health authority in your country.