Spots Global Cancer Trial Database for Phase I Clinical Study of HWH340 Tablet in Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Phase I Clinical Study of HWH340 Tablet in Patients With Advanced Solid Tumors

Official Title: A Phase I, Open-label, Single-center, Single/Multiple-dose, Dose-escalation/Dose-expansion Clinical Study on Tolerance and Pharmacokinetics of HWH340 Tablet in Patients With Advanced Solid Tumors

Study ID: NCT03415659

Conditions

Advanced Solid Tumors

HRD

BRCA Mutation

Interventions

HWH340 tablet

Study Description

Brief Summary: This is an open-label, dose-escalation/dose-expansion, phase I clinical trial study to investigate the safety, tolerability, and efficacy of HWH340. In addition, the pharmacokinetic characteristics will also be investigated. Three parts are included in this study.

Detailed Description: Part one is a single-dose study on tolerance and pharmacokinetics, in which 21-42 patients with advanced solid tumors would be enrolled. Patients will receive escalating dose groups of HWH340 tablet. Part two is a multiple-dose study on tolerance and pharmacokinetics. Based on the safety assessment, three or four groups would be chosen to conduct the study. 9-24 patients with advanced solid tumors will be enrolled. Part three is a dose expansion stage on safety and efficacy. Two to four dose-groups would be chosen to conduct the study. 40-60 patients with advanced solid tumors with BRCA mutation OR homologous recombination deficiency (HRD) will be enrolled.