Gastric Cancer Clinical Trial
Official title:
A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR106 in Patients With Select Relapsed Advanced Malignancies (JIVAN)
A Phase I, Open Label, Dose-Escalation, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR106 in Patients with Select Relapsed Advanced Malignancies (JIVAN).
This is a Phase I, Open Label, Dose-Escalation, First in Human (FIH) study in adult patients with select relapsed advanced malignancies. The safety and tolerability of oral AUR106 will be evaluated in patients with selected advanced solid tumors (Non-small cell lung cancer, Gastric cancer, Urothelial cancer, Kidney cancer, Colon cancer and Esophageal cancer), who do not have any available curative or life prolonging treatment options and have exhausted all effective locally available therapies. The traditional 3+3 design for dose escalation will be used to evaluate safety, PK/PD and determine the Optimal Biological Dose (OBD) of AUR106, as a single agent. The Optimal Biological Dose will be selected using a totality of safety, PK and PD data. ;
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