Actively Recruiting
A 2-part Phase 1/2 Open-label Trial on ODM-212
Led by Orion Corporation, Orion Pharma · Updated on 2026-05-04
229
Participants Needed
2
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An open-label, multi-site, multi-cohort phase 1/2 trial to be conducted in 2 parts (dose escalation and dose expansion/optimisation)
CONDITIONS
Official Title
A 2-part Phase 1/2 Open-label Trial on ODM-212
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants 18 years or older
- ECOG performance status of 0 or 1
- Life expectancy greater than 12 weeks according to investigator
- Ability to take oral medications and willingness to record daily adherence
- For Part 1: histologically or cytologically confirmed advanced or metastatic unresectable solid tumors eligible for study anti-cancer therapies
- Arm A: advanced mesothelioma eligible for ipilimumab/nivolumab and no prior mesothelioma surgery
- Arm B: metastatic pancreatic adenocarcinoma eligible for nab-paclitaxel and gemcitabine
- Arm C: locally advanced or metastatic NSCLC with KRAS G12C mutation, eligible and not previously treated with KRAS G12C inhibitors
- For Part 2: same disease-specific criteria as Part 1 with added requirements
- No prior treatment with ipilimumab, nivolumab, or PD-1/PD-L1/CTLA-4 inhibitors for mesothelioma cohort
- No prior nab-paclitaxel or gemcitabine for pancreatic cohort
- Measurable disease by RECIST v1.1 or modified RECIST for mesothelioma
- Availability of recent tumor tissue sample suitable for biopsy
- Amenable to paired fresh tumor biopsies at screening and on treatment
You will not qualify if you...
- Active malignancy within past 2 years except certain skin, bladder, cervical, or breast cancers treated curatively
- Chemotherapy, immunotherapy, or anti-cancer therapy within less than 2 weeks before study treatment
- Unresolved toxicities from prior cancer therapies of Grade 2 or higher (except controlled neuropathy, alopecia, endocrine disorders, asymptomatic labs)
- Radiation therapy within less than 4 weeks (definitive) or less than 2 weeks (palliative) before treatment
- Brain or subdural metastases unless asymptomatic and adequately treated
- Severe active infection within 1 week of enrollment
- Known positive hepatitis B or C or HIV infection
- Major surgery within 4 weeks or minor surgery within 1 week prior to treatment without recovery
- Use of immunosuppressive systemic medications above certain doses within 2 days before treatment
- Inability to take oral medication or conditions impairing ODM-212 absorption
- Use of other investigational drugs within required washout periods before treatment
- Use of live or live-attenuated vaccines within 28 days before study drug
- Clinically important ECG abnormalities or high risk for torsade de pointes
- Significant cardiovascular impairment or recent serious cardiac events
- Pregnant or breastfeeding women at screening or baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
NEXT Oncology
Irving, Texas, United States, 75039
Actively Recruiting
2
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
C
Clinical Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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