NCT03415659

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Hubei Biological Medicine Industrial Technology Institute Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors
• HRD
• BRCA Mutation

Interventions

Type	Name	Description
DRUG	HWH340 tablet	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.

Timeline

• Start date: 2018-03-05
• Primary completion: 2021-03-30
• Completion: 2021-09-30
• First posted: 2018-01-30
• Last updated: 2020-02-17

Locations

1 site across 1 country: China