Orion Corporation, Orion Pharma
An open-label, multi-site, multi-cohort phase 1/2 trial to be conducted in 2 parts (dose escalation and dose expansion/optimisation)
Inclusion Criteria: * Male or female participants ≥18 years old. * Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. * Life expectancy of \>12 weeks, in the opinion of the investigator. * Ability to take oral medications and willing to record daily adherence to investigational product. * Part 1: Participants with histologically or cytologically confirmed advanced or metastatic, unresectable solid tumors and who are able and willing to receive one of the anti-cancer therapies studied in this trial according to the investigator. * Arm A: Participants…
ODM-212 40mg tablet
Ipilimumab: 1 mg/kg administered intravenously over 30 minutes every 6 weeks. Nivolumab: 360 mg administered intravenously over 30 minutes every 3 weeks.
Nab-paclitaxel 125 mg/m2 administered intravenously over 30 minutes on Days 1, 8 and 15 of each 28-day cycle. Gemcitabine 1000 mg/m2 administered intravenously over 30 minutes immediately after the completion of nab-paclitaxel administration on days 1, 8 and 15 of each 28-day cycle
Sotorasib total daily dose of 960 mg taken orally q.d. every day of the 21-day cycle
Arctuva estimate
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