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

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 153

Inclusion Criteria

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 potentially harbouring a Hippo pathway alteration and, therefore, 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., 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) 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 (or witness consent; see section 11.3) prior to any study-specific screening procedures

Exclusion Criteria

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 [ß-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of ß-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 28 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 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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