Solid TumoursPhase 1/2TEADESNCT06725758
A Phase 1/2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours
A Phase 1/2 study testing ODM-212 in people with Solid Tumours, run by Orion Corporation, Orion Pharma at 20 sites in 6 countries.
Trial summary
Multi-site, open-label, first-in-human study with 2 parts (dose escalation and dose expansion) in subjects with selected advanced solid tumours Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours
- What is being tested?
- ODM-212
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 26 Oct 2023to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥18 years old
- Subjects must have histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumour of the kind listed below that is not amenable for treatment with curative intent, e.g.:
- Part 1:
- mesothelioma
- epithelioid hemangioendothelioma (EHE)
- cholangiocarcinoma (CCA)
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- 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.
- Part 2: Any solid tumour type harbouring a Hippo pathway alteration and other tumour types potentially responsive to transcriptional enhanced associate domain (TEAD) inhibition based on data from Part 1 or other existing or emerging scientific data.
- Subjects must be in need of systemic treatment for their cancer and to either be refractory to or have progressed on, are intolerant to, or are not otherwise a candidate, in the opinion of the investigator, for any of the currently available established therapies (reasons of unsuitability of standard of care treatments to be recorded).
- Part 2 only: Subjects must have measurable disease by response evaluation criteria in solid tumours (response evaluation criteria in solid tumors - RECIST) v. 1.1 (modified RECIST for malignant pleural mesothelioma - MPM).
- Part 2 only: A fresh or recent (taken up to 1 year ago) primary tumour tissue sample from a diagnostic biopsy/surgery or a tumour biopsy taken from a metastasis must be available; exemptions possible by the sponsor's decision.
- Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Life expectancy of >12 weeks.
- Willing and able to comply with all aspects of the protocol.
- Provide written informed consent (IC; or witness consent) prior to any study-specific screening procedures.
Who cannot join
- Other malignancy active within the previous 2 years except for basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast, for which the subject has completed curative therapy.
- Prior chemotherapy, immunotherapy (tumour vaccine, cytokine or growth factor given to control the cancer) or other anti-cancer therapy within less than 2 weeks before study drug administration, or any persistent unresolved toxicity from previous anti-cancer therapies of common terminology criteria for adverse events (CTCAE) Grade ≥ 2 (except for peripheral neuropathy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities). Especially, care should be exercised to exclude subjects with potential carry-over nephrotoxic effects from previous therapies (e.g., cisplatin). Luteinizing hormone releasing hormone (LHRH) agonists or antagonists are allowed as concomitant treatment.
- Prior definitive radiation therapy within less than 4 weeks and prior palliative radiotherapy within less than 2 weeks before study drug administration. Radiopharmaceuticals (strontium, samarium) within less than 8 weeks before study drug administration.
- Subjects with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and do not require treatment or have been adequately treated with local therapy.
- Known human immunodeficiency virus (HIV) infection.
- Active infection requiring therapy, including known positive tests for Hepatitis B surface antigen and hepatitis C virus (HCV) Ribonucleic acid (RNA). Pre-study testing for these pathogens is not required.
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- Major surgery within 4 weeks before the first dose of study drug or minor surgery within 1 week (subject must also have recovered from any surgery-related toxicities to less than CTCAE Grade 2).
- Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses >10 mg/day prednisone or equivalent) within 2 weeks before study drug administration.
- Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g. nausea, diarrhoea, or vomiting) that might impair the bioavailability of ODM-212.
- Use of other investigational medicinal products within 2 weeks or at least5 half-lives (whichever is longer) before study drug administration, or any persistent unresolved toxicity from such treatment that, according to the judgement of the investigator, may pose a health risk for the subject, if taking part in the study. For drugs such as investigational monoclonal antibodies with half-lives >10 days, at least 8 weeks is required. In addition, all visits (apart from survival follow-up) related to the use of another IMP must be completed before dosing with ODM-212 may commence.
- Use of any live or live-attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) within 28 days prior to the first dose of study drug.
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG; e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250 ms, a prolonged QTc interval (QTcF/B >470 ms) as demonstrated by 2 out of 3 repeated ECG at screening, performed according to local practice. A history of risk factors for torsade de pointes (e.g. heart failure, hypokalaemia, family history of long QT Syndrome) or the use of concomitant medications that prolong the QTc interval.
- Significant cardiovascular impairment: history of congestive heart failure of New York Heart Association (NYHA) Class III-IV, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke, left ventricular ejection fraction (LVEF) <50%, cardiac arrhythmia requiring medical treatment (including oral anticoagulation) within 6 months prior to the first dose of study drug.
- Female subjects who are breastfeeding or pregnant at screening or baseline.
- A separate baseline assessment for pregnancy is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- Female subjects of childbearing potential who meet any of the following criteria:
- Had unprotected sexual intercourse within 30 days before study entry or who do not agree to use a highly effective method of contraception (e.g., true abstinence if it is their preferred and usual lifestyle [defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment], an intrauterine device, a contraceptive implant, an oral contraceptive combined with a double barrier method [e.g. combination of male condom with either cap, diaphragm or sponge with spermicide], or have a vasectomized partner with confirmed azoospermia) throughout the entire treatment period and for 28 days after treatment discontinuation.
- Are neither using a highly effective method of contraception (as listed above) nor currently abstinent, or do not agree to refrain from sexual activity during the treatment period and for 28 days after treatment discontinuation.
- Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study and for 28 days after treatment discontinuation.
- Male subjects who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the treatment period and for 28 days after treatment discontinuation).
- Urine albumin/creatinine ratio ≥3 mg/mmol (category A2 urine albumin/creatinine ratio [UACR] or higher) in laboratory testing at screening, end-stage renal disease (subjects with eGFR <15 ml/min/1.73 m2, subjects on dialysis and kidney transplant recipients), moderately or severely impaired kidney function (eGFR 15-60 ml/min/1.73 m2), or any pre-existing condition associated with kidney impairment (e.g. subjects with type 1 or type 2 diabetes mellitus and confirmed nephropathy).
- Hepatic impairment defined as having any of the following laboratory values at screening: total bilirubin ≥1.5xupper limit of normal (ULN) (or >3xULN for subjects with Gilbert's syndrome), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3xULN (or ≥5xULN for subjects with liver metastasis), or albumin ≤30 g/L.
- Abnormalities in coagulation values defined as International Normalised ratio (INR) >1.5xULN at screening (unless subject is receiving anticoagulant therapy, as long as subject's laboratory values are within therapeutic range of intended use of anticoagulants).
- Haemoglobin <10 g/dL (in absence of blood transfusion within 7 days of value obtained), absolute neutrophil count <1500/µl (1.5 x 109/l), platelet count <100 000/µl (100 x 109/l).
- Any other major illness, any history of a medical condition or a concomitant medical condition that, in the investigator's judgment, will substantially increase the risk associated with, or compromise the subject's participation in this study.
- History of treatment with other TEAD inhibitors.
Trial locations and contacts
20 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 6 countries
United States8 sites, 8 recruiting
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Alexander Spira, MD, aspira@nextoncology.com
Alexander Spira, MD
- Recruiting
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Vinod Ravi, MD, vravi@mdanderson.org
Vinod Ravi, MD
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
David Berz, MD, david.berz@valkyrieclinicaltrials.com
David Berz, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Mrinal Gounder, MD, gounderm@mskcc.org
Mrinal Gounder, MD
- Recruiting
UC Irvine Health
Orange, California, 92868
Farshid Dayyani, MD, fdayyani@hs.uci.edu
Farshid Dayyani, MD
- Recruiting
Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Sarah Gordon, MD, sarah.gordon@jefferson.edu
Sarah Gordon, MD
- Recruiting
Siteman Cancer Center
St Louis, Missouri, 63110
Ayse Daylan, MD, ayseece@wustl.edu
Ayse Daylan, MD
- Recruiting
Westchester Medical Center
Valhalla, New York, 10595
Marjorie Zauderer, MD, marjorie.zauderer@wmchealth.org
Marjorie Zauderer, MD
Finland3 sites, 3 recruiting
- Recruiting
Helsinki university Hospital
Helsinki
Jalkanen, MD
Katriina Jalkanen, MD
- Recruiting
Oulu University Hospital
Oulu
Koivunen, Jussi P., MD
Jussi Koivunen, MD
- Recruiting
Turku University Hospital
Turku
Jaakkola, MD
Panu Jaakkola, MD
France3 sites, 3 recruiting
- Recruiting
Institut Bergonie
Bordeaux
Antoine Italiano, MD, a.italiano@bordeaux.unicancer.fr
Antoine Italiano, MD
- Recruiting
Centre Oscar Lambret
Lille
Loic Lebellec, MD, l-lebellec@o-labret.fr
Loic Lebellec, MD
- Recruiting
Institut Gustave Roussy
Villejuif
Yohann Loriot, MD, yohann.loriat@gustaveroussy.fr
Yohann Loriot, MD
United Kingdom3 sites, 3 recruiting
- Recruiting
Leicester Royal Infirmary
Leicester
Harriet Walter, MD, harriet.walter1@nhs.net
Harriet Walter, MD
- Recruiting
Royal Marsden Hospital, London, UK
London, SW36JJ
Johann de Bono, MD, johann.debono@icr.ac.uk
Johann de Bono, MD
- Recruiting
Weston Park Hospital
Sheffield
Sarah Danson, MD, s.danson@sheffield.ac.uk
Sarah Danson, MD
Spain2 sites, 2 recruiting
- Recruiting
Hospital 12 de Octubre
Madrid
Zugazagoitia Fraile, Jon, MD, j.zugazagoitia.imas12@h12o.es
Jon Zugazagoitia, MD
- Recruiting
Hospital Virgen De La Macarena
Seville
Vicente, MD, david.vicente.sspa@juntadeandalucia.es
David Vicente, MD
Switzerland1 site, 1 recruiting
- Recruiting
Istituto Oncologico, Ospedale Bellinzona e Valli
Bellinzona, Canton Ticino, 6500
Colombo, MD, ilaria.colombo@eoc.ch
Ilaria Colombo, MD
About this study
Multi-site, open-label, first-in-human study with 2 parts (dose escalation and dose expansion) in subjects with selected advanced solid tumours
- Conditions
- Solid Tumours
- Being tested
- ODM-212
- Keywords
- Solid Tumours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM-212Drug
ODM-212 5mg and/or 40mg tablets
| Study group | Role | What they receive |
|---|---|---|
| ODM-212 | Experimental | ODM-212 5mg and/or 40mg tablets Receives: Drug: ODM-212 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and frequency of treatment emergent adverse events (TEAE)
A TEAE is defined as any event arising or worsening after the start of treatment administration until 28 days after the last treatment intake.
Measured: From first dose to 1 year after LSLV
Severity of TEAE
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
Measured: From first dose to 1 year after LSLV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start26 Oct 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Director, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725758
- Sponsor's protocol ID
- 3134001
- Other IDs
- 2022-503061-29-00, U1111-1291-5455
- Acronym
- TEADES
- Status last verified
- Jan 2026
- First submitted
- 29 Nov 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT06725758
- Acronym / sponsor ID
- TEADES / 3134001
- Conditions
- Solid Tumours
- Keywords
- Solid Tumours
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-site, open-label, first-in-human study with 2 parts (dose escalation and dose expansion) in subjects with selected advanced solid tumours
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ODM-212 | Experimental | Drug: ODM-212ODM-212 5mg and/or 40mg tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Male or female subjects ≥18 years old
- Subjects must have histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumour of the kind listed below that is not amenable for treatment with curative intent, e.g.:
- Part 2: Any solid tumour type harbouring a Hippo pathway alteration and other tumour types potentially responsive to transcriptional enhanced associate domain (TEAD) inhibition based on data from Part 1 or other existing or emerging scientific data.
- Subjects must be in need of systemic treatment for their cancer and to either be refractory to or have progressed on, are intolerant to, or are not otherwise a candidate, in the opinion of the investigator, for any of the currently available established therapies (reasons of unsuitability of standard of care treatments to be recorded).
- Part 2 only: Subjects must have measurable disease by response evaluation criteria in solid tumours (response evaluation criteria in solid tumors - RECIST) v. 1.1 (modified RECIST for malignant pleural mesothelioma - MPM).
Key exclusion criteria (26 listed)
- Other malignancy active within the previous 2 years except for basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast, for which the subject has completed curative therapy.
- Prior chemotherapy, immunotherapy (tumour vaccine, cytokine or growth factor given to control the cancer) or other anti-cancer therapy within less than 2 weeks before study drug administration, or any persistent unresolved toxicity from previous anti-cancer therapies of common terminology criteria for adverse events (CTCAE) Grade ≥ 2 (except for peripheral neuropathy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities). Especially, care should be exercised to exclude subjects with potential carry-over nephrotoxic effects from previous therapies (e.g., cisplatin). Luteinizing hormone releasing hormone (LHRH) agonists or antagonists are allowed as concomitant treatment.
- Prior definitive radiation therapy within less than 4 weeks and prior palliative radiotherapy within less than 2 weeks before study drug administration. Radiopharmaceuticals (strontium, samarium) within less than 8 weeks before study drug administration.
- Subjects with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and do not require treatment or have been adequately treated with local therapy.
- Known human immunodeficiency virus (HIV) infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ODM-212ODM-212 5mg and/or 40mg tablets | Drug | ODM-212 |
Primary outcome
Incidence and frequency of treatment emergent adverse events (TEAE)
Time frame: 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 TEAE
Time frame: From 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Study Director study director
Orion Corporation, Orion Pharma
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ODM-212 in people with Solid Tumours, run by Orion Corporation, Orion Pharma at 20 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Finland, France, United Kingdom, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Study Director (+358104261, clinicaltrials@orionpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and frequency of treatment emergent adverse events (TEAE) (time frame: From first dose to 1 year after LSLV). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.