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

Part of paid clinical trials in Irving, Texas.

Sponsor
Orion Corporation, Orion Pharma
Study ID
NCT07563738
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ODM-212 — DRUG
    ODM-212 40mg tablet
  • Ipilimumab and nivolumab — DRUG
    Ipilimumab: 1 mg/kg administered intravenously over 30 minutes every 6 weeks. Nivolumab: 360 mg administered intravenously over 30 minutes every 3 weeks.
  • Gemcitabine and nab-paclitaxel — DRUG
    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 — DRUG
    Sotorasib total daily dose of 960 mg taken orally q.d. every day of the 21-day cycle

Study Details

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

Key Dates

Start date
Mar 27, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
229 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ODM-212 with ipilimumab/nivolumab in mesothelioma
  • Experimental: ODM-212 with gemcitabine and nab-paclitaxel in PDAC
  • Experimental: ODM-212 with sotorasib in NSCLC

Primary Outcome Measure

Incidence of Dose Limiting Toxicities and Adverse Events [ Time Frame: Through study completion, on average of 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NEXT OncologyIrvingTexas75039
Michael Song, MD
NEXT Oncology VirginiaFairfaxVirginia22031
Alexander Spira, MD
[email protected]

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