Two-part, First-in-human Study on ODM-212 in Subjects with Selected Advanced Solid Tumours
Study Description
Multi-site, open-label, first-in-human study with 2 parts (dose escalation and dose expansion) in subjects with selected advanced solid tumours
Eligibility
-You 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
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.
-You 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: You 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.
-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 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.
-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).
-Major surgery within 4 weeks before the first dose of stud
