Authorised Phase I and Phase II (Integrated)- First administration to humans Neoplasms benign malignant and unspecified (incl cysts and polyps). MedDRA [C04]

FIRST IN-HUMAN STUDY EVALUATING THE EFFECT OF VARIOUS DOSES OF ODM-212 IN SUBJECTS WITH SELECTED ADVANCED SOLID TUMOURS

EU CTIS ID: 2022-503061-29-00

What this study is testing

Part 1 of the CT: to evaluate the safety and tolerability profile of ODM-212 as a single agent administered orally in subjects with selected advanced solid tumours. Part 2A of the CT: to define the optimal dose(s) for further clinical trials. Part 2B: to evaluate preliminary antitumour efficacy of ODM-212 in selected tumours.

  • Phase I and Phase II (Integrated)- First administration to humans

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Male or female subjects ≥18 years old
  • Subjects must have histological diagnosis of local advanced or metastatic solid tumour with available local data for loss-of-function genetic alterations in NF2/LATS1/LATS2, or YAP/TAZ fusions; Part 2 of the CT: Any solid tumour type harbouring a Hippo pathway alteration and other tumour types, potentially responsive to 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 for unsuitability of standard of care treatments to be recorded).
  • Part 2 of the CT only: Subjects must have measurable disease by response evaluation criteria in solid tumours (RECIST v. 1.1 or modified RECIST for MPM).
  • Part 2 of the CT only: A fresh or 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. Exemptions possible by the sponsor’s decision.
  • Performance status 0-1 on the Easter Cooperative Oncology Group (ECOG) Performance Scale

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 situ of the cervix or breast, for which the subject has completed curative therapy.
  • Use of other investigational medicinal products within 2 weeks or at least 5 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 QTcF/B interval (QTc >470 ms) as demonstrated by 2 out 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 (as documented by a positive beta-human chorionic gonadotropin [β-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG).
See the full eligibility criteria
Who can join
  • Male or female subjects ≥18 years old
  • Subjects must have histological diagnosis of local advanced or metastatic solid tumour with available local data for loss-of-function genetic alterations in NF2/LATS1/LATS2, or YAP/TAZ fusions; Part 2 of the CT: Any solid tumour type harbouring a Hippo pathway alteration and other tumour types, potentially responsive to 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 for unsuitability of standard of care treatments to be recorded).
  • Part 2 of the CT only: Subjects must have measurable disease by response evaluation criteria in solid tumours (RECIST v. 1.1 or modified RECIST for MPM).
  • Part 2 of the CT only: A fresh or 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. Exemptions possible by the sponsor’s decision.
  • Performance status 0-1 on the Easter 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 (or witness consent; see section 11.3) 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 curative therapy.
  • Use of other investigational medicinal products within 2 weeks or at least 5 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 QTcF/B interval (QTc >470 ms) as demonstrated by 2 out 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 (as documented by a positive beta-human chorionic gonadotropin [β-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG).
  • 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 90 days after study drug 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 90 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 90 days after treatment discontinuation. NOTE: All female subjects will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (i.e. total hysterectomy, or bilateral oophorectomy, with surgery at least 1 month before dosing).
  • 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 90 days after treatment discontinuation). No sperm donation is allowed during the treatment period and for 90 days after study drug discontinuation.
  • Urine albumin/creatinine ratio ≥3 mg/mmol (category A2 urine albumin/creatinine ratio [UACR] or higher) in laboratory testing at screening, or moderately impaired kidney function (eGFR ≤ 60 ml/min/1.73m2). In Part 2 UACR ≥10 mg/mmol at screening will lead to exclusion. In Part 2, estimated glomerular filtration rate (eGFR) is calculated as follows: eGFR (ml/min) = eGFR (ml/min/1.73 m²) × (BSA (m²))/1.73 where the body surface area (BSA) is calculated using e.g. the Mosteller formula: BSA = √[(Height (cm) × Weight (kg)) / 3600]
  • Hepatic impairment defined as having any of the following laboratory values at screening: total bilirubin ≥1.5xULN (or >3xULN for subjects with Gilbert’s syndrome), AST or ALT >3xULN (or >5xULN for subjects with liver metastasis), or albumin ≤30 g/L.
  • 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 such 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). Especially, care should be exercised to exclude subjects with potential carry-over nephrotoxic effects from previous therapies (e.g., cisplatin). 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).
  • Abnormalities in coagulation values defined as having 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.
  • 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. Confirmation of radiographic stability must be done by comparing the brain scan (CT or MRI) performed during the screening period to a brain scan performed at least 4 weeks earlier (and following local therapy where applicable) using the same imaging modality as during the screening period. It is not the intention of this protocol to treat subjects with active brain metastasis.
  • Known human immunodeficiency virus (HIV) infection
  • Active infection requiring therapy, including known positive tests for Hepatitis B surface antigen and hepatitis C virus (HCV) RNA. Prestudy 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.

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom
  • Switzerland
  • United States

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; Switzerland; United States. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.