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

First listed
May 4, 2026
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]

Find similar trials in Irving, TX

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