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A Phase I, Open-Label, Multi-Center Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-017 Monotherapy in Patients With Advanced Solid Tumors and Hematological Malignancies
Antengene Therapeutics Limited
This study will contain two groups of patients; those with solid cancers (the solid tumours groups) and those with cancers of the blood (the haematological malignancies group). Oral ATG-017 will be administered on an empty stomach once daily in the solid tumours group. In the haematological malignancies group, ATG-017 will be administered twice a day, 12 hours apart (no food or drink other than water for 2 hours prior to, and for 1 hour after study treatment administration). All doses of ATG-017 should/will be taken at approximately the same time each day. Dosing will start at 5mg per day and study treatment 'cycles' will be defined as 21 days. Once a maximum tolerated dose/recommended dose is identified, dose expansion can/will commence with the aim of further evaluating the safety, tolerability and pharmacokinetics of ATG-017.