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A Phase 1a/b, open-label, dose-exploration, combination/ expansion study to evaluate the safety, tolerability and pharmacokinetics of Auceliciclib in advanced solid tumours and in combination with temozolomide in recurrent or newly diagnosed Glioblastoma multiforme (GBM)
Aucentra Therapeutics Pty Ltd.
This is a non-randomised trial with Dose Exploration and Disease Expansion phases. In the Dose Exploration phase, one cohort will be recruited sequentially for each dose level. All participants receive each dose in the Dose Exploration Phase until the maximum tolerated dose is reached. The Dose Exploration Phase involves participants with solid tumours. In the Disease Expansion Phase, there are three arms: Arm 1 involves those with ovarian cancer, Arm 2 involves those with colorectal cancer, and Arm 3 involves those with glioblastoma multiforme (GBM). For Dose Exploration and Disease Expansion (Arms 1 & 2) phases, Auceliciclib oral capsules will be administered daily for 21 days of each cycle. For Disease Expansion phase (Arm 3), Auceliciclib will be administered daily for 16 days of each cycle and Temozolomide will be administered for 5 days of each cycle.