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Two-part, First-in-human Study on ODM-212 in Subjects with Selected Advanced Solid Tumours

Cancer
Farshid Dayyani
Brain and Nervous System
Colon
Lip Oral Cavity and Pharynx
Liver
Lung
Other Male Genital
Prostate
Rectum
Small Intestine

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

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