Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Xennials Therapeutics Australia Pty Ltd
With
Dose Exploration (Phase 1a, n\~25): This part of the study will assess the safety and tolerability of NTX-301 and to identify the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). It will initiate with a dose escalation using a 3+3 design. Combination Dose and Disease Expansion (Phase 1b-2a, n\~60): The study will be expanded in specific subsets of patients with solid tumours and with combination therapy as follows: * Arm 1 (Phase 1b, n\~20): Dose Escalation, NTX-301 platinum-based doublet therapy * Arm 2 (Phase 2a, n\~40): Dose Expansion, NTX-301 platinum-based doublet therapy Patients with advanced ovarian \& bladder cancer considered to be incurable by the investigator and for which available anti-cancer therapy has been exhausted will be enrolled for this component. Patients will be given NTX-301 at the MTD determined in Phase 1a. This will be combined with a platinum-based agent that will be administered by IV infusion. Optional Cohort -High-Grade Glioma Combination Dose \& Disease Expansion (Phase 1b-2a, n\~40) * Arm 3 (Phase 1b, n\~20): Dose Escalation, NTX-301 combination therapy with TMZ * Arm 4 (Phase 2a, n\~20): Dose Expansion, NTX-301 combination therapy with TMZ Patients with IDH1 mutated high-grade glioma that have commenced initial chemoradiotherapy with temozolomide and are yet to commence Temozolomide maintenance therapy will be enrolled for this component. Patients will be given NTX-301 at the MTD determined in Phase 1a. This will be combined with TMZ that will be administered orally.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
