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An Open-label, Multi-centre, Phase I/II Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of CN1 in Combination With CN401 in Adult Patients With Relapsed/Refractory Lymphoid Malignancies
Curon Biopharmaceutical (Australia) Co Pty Ltd
This is an non-randomised, open-label study, investigating two study drugs CN1 and CN401 and will be conducted in two parts: Phase 1 and Phase 2. Phase 1 is a dose-finding study for the assessment of dose limiting toxicities (DTLs) in patients with advanced lymphoid malignancies. Phase 1 has five different dose level cohorts. CN1 will be administered on Day 1 of each cycle (once every three weeks) via intravenous infusion for up to 12 months and CN401 will be administered via oral tablet twice daily. Dose levels will vary depending on which cohort a participant is in. Phase 2 is an expansion study evaluating the preliminary efficacy of CN1 in combination with CN401 at the RP2D in parallel patient cohorts grouped by non-Hodgkin's Lymphoma (NHL) subtype.