1. single escalating dose study starts from 20 mg as the initial dose until the maximum dose group (520mg) or maximum tolerated dose (MTD) has been reached.
2. multiple-dose study conducted on oral HWH340 tablet BID. The DLTs evaluating period is 4 weeks and the safety evaluation period lasts till 4 weeks after drug withdrawal.
3. dose-expansion study conducted on oral HWH340 tablet BID in 2 to 4 dose groups. Patients with BRCA mutation OR HRD will be assigned to 2 cohort in each dose group.

HWH340 tablet

HE Zhenyu

SUN Wenjie

Tong Zhongsheng

TONG Zhongsheng

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.

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.

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

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

Number of Participants with adverse events

The laboratory test included: hematology, chemistry, urinalysis, and other tests

Blood samples are obtained and plasma concentrations of HWH340 are determined using a validated atomic absorption spectrometry method.

Response and progression is evaluated using internationally accepted response criteria and definitions proposed by the RECIST criteria.

AUC referred to area under the plasma concentration-time curve post dose.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I Clinical Study of HWH340 Tablet in Patients With Advanced Solid Tumors	NCT03415659	Advanced Solid ... HRD BRCA Mutation	HWH340 tablet	18 Years - 70 Years	Hubei Biological Medicine Industrial Technology Institute Co., Ltd.
Phase I Clinical Study of HWH340 Tablet in Patients With Advanced Solid Tumors	NCT03415659	Advanced Solid ... HRD BRCA Mutation	HWH340 tablet	18 Years - 70 Years	Hubei Biological Medicine Industrial Technology Institute Co., Ltd.

Spots Global Cancer Trial Database for hwh340

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Spots Global Cancer Trial Database for hwh340

Every month we try and update this database with for hwh340 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hwh340 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.