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New treatment option for Solid Tumours
Official title A Phase 1/2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours
ClinicalTrials.gov ID: NCT06725758
What this study is testing
What is ODM-212?
ODM-212 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for solid tumours.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Multi-site, open-label, first-in-human study with 2 parts (dose escalation and dose expansion) in subjects with selected advanced solid tumours
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female people ≥18 years old
- people must have histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumour of the kind listed below that is not...
- mesothelioma
- epithelioid hemangioendothelioma (EHE)
- cholangiocarcinoma (CCA)
You likely can't join if
- Other malignancy active within the previous 2 years except for basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in...
- Prior chemotherapy, immunotherapy (tumour vaccine, cytokine or growth factor given to control the cancer) or other anti-cancer therapy within less...
- Prior definitive radiation therapy within less than 4 weeks and prior palliative radiotherapy within less than 2 weeks before study drug...
- people with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and do not require treatment or have been...
- 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...
See the full eligibility criteria
Who can join
- Male or female people ≥18 years old
- people 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)
- 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...
- 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...
- people 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...
- Part 2 only: people 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- people 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.
- 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...
- 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...
- 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...
- 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...
- Female people 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 people 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...
- Male people 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...
- 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 (people with eGFR \<15 ml/min/1.73 m2, people on...
- Hepatic impairment defined as having any of the following laboratory values at screening: total bilirubin ≥1.5xupper limit of normal (ULN) (or \>3xULN for people with Gilbert's syndrome), aspartate aminotransferase...
- 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...
- 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...
- History of treatment with other TEAD inhibitors.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orange, California, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Valhalla, New York, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Helsinki, Finland
- Oulu, Finland
- Turku, Finland
- Bordeaux, France
- Lille, France
- Villejuif, France
- Madrid, Spain
- Seville, Spain
- Bellinzona, Canton Ticino, Switzerland
- Leicester, United Kingdom
- London, United Kingdom
- Sheffield, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orange, California, United States; St Louis, Missouri, United States; New York, New York, United States; Valhalla, New York, United States; Philadelphia, Pennsylvania, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.