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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

2026-10-22

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 (23)

Valkyrie Clinical Trials

Los Angeles, California, United States

UC Irvine Health

Orange, California, United States

START Dallas-Fort Worth

Fort Worth, Texas, United States

NEXT Oncology

Irving, Texas, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

Aalborg Universitets hospital

Aalborg, Denmark

Rigshospitalet University

Copenhagen, Denmark

Helsinki University Hospital

Helsinki, Finland

Turku University Hospital

Turku, Finland

Institut Bergonie

Bordeaux, France

Marseille University Hospital Timone

Marseille, France

CHU de Poitiers

Poitiers, France

Gustave Roussy

Villejuif, France

HM Nou Delfos

Barcelona, Spain

ICO Hospitale

Barcelona, Spain

Vall D'Hebron University Hospital

Barcelona, Spain

HM Sanchinarro

Madrid, Spain

Hospital 12 de Octubre

Madrid, Spain

START Madrid FJD

Madrid, Spain

Ospedale Regionale Bellinzona

Bellinzona, Switzerland

Leicester Royal Infirmary

Leicester, United Kingdom

Royal Marsden Hospital

London, United Kingdom

University Hospital Southampton

Southampton, United Kingdom