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Phase 1/2 Study of ODM-212 for Advanced Solid Tumours

This study is testing a new drug called ODM-212 in people with advanced solid tumours that cannot be cured with standard treatments. It's a "first-in-human" study, meaning it's the first time ODM-212 is being given to people. The main goal is to see how safe ODM-212 is and what side effects it might cause. Researchers will be looking at how often side effects happen and how severe they are for up to one year after your last dose. You may be able to join if you are at least 18 years old and have certain types of advanced solid tumours, such as mesothelioma or cholangiocarcinoma. The current recruitment status is unclear.

Study design
This is a multi-site, open-label study with two parts: dose escalation (finding the right dose) and dose expansion (testing that dose in more people). It plans to include 315 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for side effects for up to one year after your last study drug dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06725758

A Phase 1/2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours

Recruiting
PHASE1Ages 18+InterventionalTreatment
Orion Corporation, Orion Pharma
~315 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:ODM-212

At a glance

Recruiting sites
20 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and frequency of treatment emergent adverse events (TEAE)
Measured over From first dose to 1 year after LSLV
+1 more outcome measured

Conditions

Solid Tumours

Explore related trials

CholangiocarcinomaColorectal CarcinomaEpithelioid HemangioendotheliomaHead and Neck Squamous Cell CarcinomaHepatocellular CarcinomaLung Non-Small Cell CarcinomaMeningiomaMesothelial NeoplasmProstate CarcinomaSolid Neoplasm

Where it's being run

20 sites across 11 states
Finland3
France3
United Kingdom3
California2
New York2
Spain2
Missouri1
Pennsylvania1

Study leadership

  • Clinical Study Director · STUDY_DIRECTOR · Orion Corporation, Orion Pharma

Who to contact

Clinical Study Director
[email protected]
+358104261
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

mesothelioma
epithelioid hemangioendothelioma (EHE)
cholangiocarcinoma (CCA)
head and neck squamous cell carcinoma (HNSCC)
non-small cell lung carcinoma (NSCLC)
colorectal cancer (CRC)
hepatocellular cancer (HCC)
castration-resistant prostate cancer (CRPC)
meningioma
any other solid tumours with available local data for loss-of-function genetic alterations (truncating mutations or gene deletion) in neurofibrin 2 (NF2)/large tumour suppressor kinase (LATS1/LATS2), or Yes-associated protein/ Transiptional coactivator with PDZ-binding motif (YAP/TAZ) fusions
any other solid tumour based on emerging scientific data as per sponsor's decision.

What this trial measures

  • Incidence and frequency of treatment emergent adverse events (TEAE)From first dose to 1 year after LSLV

    A TEAE is defined as any event arising or worsening after the start of treatment administration until 28 days after the last treatment intake.

  • Severity of TEAEFrom first dose to 1 year after LSLV

    All AEs (except proteinuria which is to be graded according to urine albumin/creatinine ratio (UACR) category) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0