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Brief Title: MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class
Official Title: MTH1, A Phase I, Study on Tumors Inhibition, First in Human, First in Class
Study ID: NCT03036228
Brief Summary: Primary Objective • To determine the safety and tolerability of Karonudib (TH1579) in escalating doses for the treatment of patients with advanced solid malignant tumours. Secondary Objective * To define DLT and MTD. * To determine a recommended phase 2 dose (RP2D) and schedule. * To determine the pharmacokinetics of Karonudib. * To determine preliminary signs of clinical efficacy of Karonudib. * To determine overall survival.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Karolinska University Hospital, Stockholm, , Sweden
Name: Teresa Sandvall, MSc
Affiliation: Oxcia
Role: STUDY_DIRECTOR