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RECRUITING
NCT07563738
PHASE1/PHASE2

A 2-part Phase 1/2 Open-label Trial on ODM-212

Sponsor: Orion Corporation, Orion Pharma

View on ClinicalTrials.gov

Summary

An open-label, multi-site, multi-cohort phase 1/2 trial to be conducted in 2 parts (dose escalation and dose expansion/optimisation)

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

229

Start Date

2026-03-27

Completion Date

2029-09

Last Updated

2026-05-04

Healthy Volunteers

No

Interventions

DRUG

ODM-212

ODM-212 40mg tablet

DRUG

Ipilimumab 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.

DRUG

Gemcitabine 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

DRUG

sotorasib

Sotorasib total daily dose of 960 mg taken orally q.d. every day of the 21-day cycle

Locations (2)

NEXT Oncology

Irving, Texas, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States