A 2-part Phase 1/2 Open-label Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ODM-212 in Combination With Anti-cancer Therapy in Participants With Advanced Solid Tumours
Orion Corporation, Orion Pharma
Summary
An open-label, multi-site, multi-cohort phase 1/2 trial to be conducted in 2 parts (dose escalation and dose expansion/optimisation)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugODM-212
ODM-212 40mg tablet
- DrugIpilimumab and nivolumab
Ipilimumab: 1 mg/kg administered intravenously over 30 minutes every 6 weeks. Nivolumab: 360 mg administered intravenously over 30 minutes every 3 weeks.
- DrugGemcitabine and nab-paclitaxel
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
- Drugsotorasib
Sotorasib total daily dose of 960 mg taken orally q.d. every day of the 21-day cycle
Locations (2)
- NEXT OncologyIrving, Texas
- NEXT Oncology VirginiaFairfax, Virginia