Actively Recruiting
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
Led by Orion Corporation, Orion Pharma ยท Updated on 2026-05-04
229
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an open-label, multi-site, multi-cohort phase 1/2 trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ODM-212 combined with anti-cancer therapies in participants with advanced solid tumors, including mesothelioma, pancreatic cancer, and advanced non-small cell lung cancer (NSCLC). The study aims to understand how ODM-212 works alongside other treatments in these serious cancers. The trial has two parts: dose escalation and dose expansion/optimization. Participants receive ODM-212 tablets along with other anti-cancer drugs depending on their cancer type. For mesothelioma, ODM-212 is combined with ipilimumab and nivolumab given intravenously on specific schedules. For pancreatic cancer, it is combined with gemcitabine and nab-paclitaxel administered intravenously in cycles. For NSCLC with a KRAS G12C mutation, ODM-212 is combined with sotorasib taken orally daily in 21-day cycles. Participants will be closely monitored throughout the study, with evaluations of side effects, dose-limiting toxicities, and adverse events tracked on average for two years. The research team will collect tumor tissue samples, monitor treatment adherence, and perform assessments to measure disease status and treatment effects. Safety will be carefully checked with exams, ECGs, and laboratory tests. The study is planned to continue through 2029, with ongoing visits and follow-ups as part of participant involvement.
CONDITIONS
Brief 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 old or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than 12 weeks as judged by the investigator
- Ability to take oral medications and willingness to record daily adherence to the study drug
- Part 1: Participants with confirmed advanced or metastatic, unresectable solid tumors eligible for one of the anti-cancer therapies in the trial
- Arm A: Advanced mesothelioma diagnosis eligible for ipilimumab/nivolumab treatment without prior surgical therapy
- Arm B: Metastatic pancreatic adenocarcinoma eligible for nab-paclitaxel and gemcitabine treatment
- Arm C: Locally advanced or metastatic NSCLC with KRAS G12C mutation, having received first-line treatment and eligible for sotorasib without prior KRAS G12C inhibitor treatment
- Part 2: Participants matching the above cancer types eligible for respective treatments, with measurable disease and available tumor tissue samples
- Amenable to paired fresh tumor biopsies at screening and on-treatment
You will not qualify if you...
- Other active malignancy within the last 2 years except certain skin, bladder, cervical, or breast cancers with completed curative therapy
- Chemotherapy, immunotherapy, or other anti-cancer treatments within less than 2 weeks before trial treatment
- Persistent unresolved toxicity from previous anti-cancer therapies of CTCAE Grade 2 or higher, except specified controlled conditions
- Recent radiation therapy less than 4 weeks (definitive) or less than 2 weeks (palliative)
- Brain or subdural metastases unless asymptomatic and adequately treated
- Severe active infection within 1 week of enrollment
- Known positive hepatitis B, hepatitis C, or HIV infection unless clinically ruled out
- Major surgery within 4 weeks or minor surgery within 1 week before first dose without recovery
- Use of immunosuppressive systemic medications above certain doses within 2 days before treatment
- Inability to take oral medication or gastrointestinal conditions impairing drug absorption
- Use of other investigational drugs within specified washout periods or unresolved toxicities
- Use of live or live-attenuated vaccines within 28 days before first dose
- Significant ECG abnormalities or history of certain heart conditions
- Severe cardiovascular impairment including heart failure class III-IV or recent cardiac events
- Female participants who are pregnant or breastfeeding at screening or baseline without confirmed negative pregnancy test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Varies by treatment cycle and continues until disease progression or discontinuation
Participants receive ODM-212 in combination with one of the anti-cancer therapies: ipilimumab and nivolumab, gemcitabine and nab-paclitaxel, or sotorasib. Treatment involves oral and intravenous medications administered in cycles according to their assigned therapy.
Visits coincide with treatment cycles, including intravenous infusions on specified days and daily oral medication intake
Duration - Up to 2 years on average
Participants are monitored for dose-limiting toxicities and adverse events after treatment completion, with ongoing safety and efficacy assessments.
Regular visits for safety and efficacy monitoring as scheduled by the study team
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
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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