MesotheliomaPhase 1/2TEADCONCT07563738
A 2-part Phase 1/2 Open-label Trial on ODM-212
A Phase 1/2 study testing ODM-212, Ipilimumab and nivolumab and Gemcitabine and nab-paclitaxel in people with Mesothelioma and Pancreatic Cancer, run by Orion Corporation, Orion Pharma at 23 sites in 7 countries.
Trial summary
An open-label, multi-site, multi-cohort phase 1/2 trial to be conducted in 2 parts (dose escalation and dose expansion/optimisation) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma, Pancreatic Cancer, NSCLC (Advanced Non-small Cell Lung Cancer)
- What is being tested?
- ODM-212, Ipilimumab and nivolumab and Gemcitabine and nab-paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 23 sitesin 7 countries
- Study dates
- 27 Mar 2026to Sep 2029
- Phase
- Phase 1/2
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 participants ≥18 years old.
- Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Life expectancy of >12 weeks, in the opinion of the investigator.
- Ability to take oral medications and willing to record daily adherence to investigational product.
- Part 1: Participants with histologically or cytologically confirmed advanced or metastatic, unresectable solid tumors and who are able and willing to receive one of the anti-cancer therapies studied in this trial according to the investigator.
- Arm A: Participants with histologically or cytologically confirmed diagnosis of advanced (unresectable or metastatic) mesothelioma who are eligible to receive treatment with ipilimumab/nivolumab; participants must not have undergone surgical therapy for mesothelioma.
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- Arm B: Participants with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas who are eligible to receive treatment with nab-paclitaxel and gemcitabine.
- Arm C: Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and a KRAS G12C-mutation, confirmed using a validated test, who have received the available 1st line treatment and who are eligible for a treatment with sotorasib and have not received a KRAS G12C inhibitor as prior treatment.
- Part 2:
- Ipilimumab/nivolumab cohort: Participants with histologically or cytologically confirmed diagnosis of advanced (unresectable or metastatic) mesothelioma who are eligible to receive a treatment with ipilimumab/nivolumab. Prior treatment with ipilimumab, nivolumab and/or other PD-1/PD-L1/CTLA-4 inhibitors for advanced or metastatic disease is not allowed.
- Nab-paclitaxel/gemcitabine cohort: Participants with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas who are eligible to receive a treatment with nab-paclitaxel and gemcitabine. Previous treatments with nab-paclitaxel and/or gemcitabine for metastatic disease are not allowed.
- Sotorasib cohort, treatment naïve: Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and a KRAS G12C-mutation, confirmed using a validated test, who are eligible for a treatment with sotorasib and have not received a KRAS G12C inhibitor as prior treatment.
- Sotorasib cohort, pretreated: Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and a KRAS G12C mutation, confirmed using a validated test, who have documented progression on a prior KRAS G12C inhibitor (approved or investigational).
- Part 2 only: Participants must have measurable disease by response evaluation criteria in solid tumours (RECIST) v. 1.1 (modified RECIST for MPM).
- A recent (taken up to 1 year ago), representative tumour tissue sample (from primary tumour or from metastasis) must be available. Tissue must be a core needle biopsy, excisional or incisional biopsy. Biopsies of bone lesions that do not have a soft tissue component or decalcified bone tumour samples are also not acceptable.
- Amenable for paired fresh tumour biopsy at screening period and on-treatment.
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 participants has completed curative therapy.
- Prior chemotherapy, immunotherapy (immune checkpoint inhibitor, tumour vaccine, cytokine or growth factor given to control the cancer) or other anti-cancer therapy within less than 2 weeks before trial treatment administration.
- Any persistent unresolved toxicity from previous anti-cancer therapies of CTCAE Grade ≥ 2 (except for peripheral neuropathy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities). Ongoing adjuvant treatments for previous cancers are allowed as concomitant treatments if they do not have direct anti-tumour effect on the index tumour (e.g. hormone-suppressing agents).
- Prior definitive radiation therapy within less than 4 weeks and prior palliative radiotherapy within less than 2 weeks before trial treatment administration. Radiopharmaceuticals should be expected to have cleared sufficiently from the participant's body before trial treatment administration.
- Participants with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and have been adequately treated with local therapy.
- Any severe active infection within 1 week of trial enrolment.
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- Known positive tests for hepatitis B surface antigen or hepatitis C virus (HCV) RNA; known human immunodeficiency virus (HIV) infection. Screening test is not required unless participant has clinical findings suggestive of HIV, HBV or HCV infection.
- Major surgery within 4 weeks before the first dose of trial treatment or minor surgery within 1 week (participant 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 days before trial treatment 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 least 5 half-lives (whichever is longer) before trial treatment administration, or any persistent unresolved toxicity from such treatment that, according to the judgement of the investigator, may pose a health risk for the participant, if taking part in the trial. 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 trial treatments may commence.
- Use of any live or live-attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, shingles, 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 drugs that prolong the QT interval and are clearly associated with a known risk of torsade de pointes, even when taken as recommended per Crediblemeds.org QTdrugs list.
- 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 trial treatment.
- Female participants 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.
Trial locations and contacts
23 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 7 countries
Spain6 sites, 6 recruiting
- Recruiting
HM Nou Delfos
Barcelona
Roberto Martin Huertas, Roberto.Martin@startresearch.com
- Recruiting
ICO Hospitale
Barcelona
Maria Jove Casulleras, MD, mjove@iconcologia.net
- Recruiting
Vall D'Hebron University Hospital
Barcelona
Susana Maria Cedres Perez, MD, scedres@vhio.net
- Recruiting
HM Sanchinarro
Madrid
Juan Jose Soto Castillo, MD, juanj.soto@startmadrid.com
- Recruiting
Hospital 12 de Octubre
Madrid
Jon Zugazagoitia, MD, j.zugazagoitia.imas12@h12o.es
- Recruiting
START Madrid FJD
Madrid
Victor Moreno Garcia, MD, victor.moreno@startmadrid.com
United States5 sites, 5 recruiting
- Recruiting
NEXT Oncology Virginia
Fairfax, Virginia, 22031
Alexander Spira, MD, aspira@nextoncology.com
- Recruiting
START Dallas-Fort Worth
Fort Worth, Texas, 76104
Henry Xiong, hxiong@txcc.com
Henry Xiong, MD
- Recruiting
NEXT Oncology
Irving, Texas, 75039
Michael Song, MD
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
David Berz, MD, david.berz@valkyrieclinicaltrials.com
- Recruiting
UC Irvine Health
Orange, California, 92868
Farshid Dayyani, fdayyani@hs.uci.edu
Farshid Dayyani, MD
France4 sites, 4 recruiting
- Recruiting
Institut Bergonie
Bordeaux
Veronique Debien, MD, v.debien@bordeaux.unicancer.fr
- Recruiting
Marseille University Hospital Timone
Marseille
Laurent Greillier, MD, laurent.greillier@ap-hm.fr
- Recruiting
CHU de Poitiers
Poitiers
Nicolas Isambert, MD, nicolas.isambert@chu-poitiers.fr
- Recruiting
Gustave Roussy
Villejuif
Antoine Hollebecque, MD, antoine.hollebecque@gustaveroussy.fr
United Kingdom3 sites, 3 recruiting
- Recruiting
Leicester Royal Infirmary
Leicester
Harriet Walter, MD, harriet.walter1@nhs.net
- Recruiting
Royal Marsden Hospital
London
Sanjaykumar Popat, MD, Sanjay.Popat@rmh.nhs.uk
- Recruiting
University Hospital Southampton
Southampton
Ioannis Karydis, MD, i.karydis@soton.ac.uk
Denmark2 sites, 2 recruiting
- Recruiting
Aalborg Universitets hospital
Aalborg
Weronika Szejniuk, MD, wms@rn.dk
- Recruiting
Rigshospitalet University
Copenhagen
Kristoffer Staal Rohrberg, MD, kristoffer.staal.rohrberg@regionh.dk
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Katriina Jalkanen, MD, katriina.jalkanen@hus.fi
- Recruiting
Turku University Hospital
Turku
Panu Jaakkola, MD, panjaa@utu.fi
Switzerland1 site, 1 recruiting
- Recruiting
Ospedale Regionale Bellinzona
Bellinzona
Martina Imbimbo, martina.imbimbo@eoc.ch
About this study
Official title: 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
An open-label, multi-site, multi-cohort phase 1/2 trial to be conducted in 2 parts (dose escalation and dose expansion/optimisation)
- Being tested
- ODM-212, Ipilimumab and nivolumab, Gemcitabine and nab-paclitaxel, sotorasib
- Medical subject headings
- Mesothelioma, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM-212Drug
ODM-212 40mg tablet
Ipilimumab and nivolumabDrug
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-paclitaxelDrug
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
sotorasibDrug
Sotorasib total daily dose of 960 mg taken orally q.d. every day of the 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| ODM-212 with ipilimumab/nivolumab in mesothelioma | Experimental | Not described Receives: Drug: ODM-212; Drug: Ipilimumab and nivolumab |
| ODM-212 with gemcitabine and nab-paclitaxel in PDAC | Experimental | Not described Receives: Drug: ODM-212; Drug: Gemcitabine and nab-paclitaxel |
| ODM-212 with sotorasib in NSCLC | Experimental | Not described Receives: Drug: ODM-212; Drug: sotorasib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities and Adverse Events
Incidence and severity of adverse events and clinical laboratory abnormalities
Measured: Through study completion, on average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start27 Mar 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 229 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563738
- Sponsor's protocol ID
- 3134003
- Acronym
- TEADCO
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No