NCT03583125

Study of EOC317 in Chinese Patients With Advanced Solid Tumors

A Phase 1 Dose Escalation Study of EOC317 in Chinese Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Taizhou EOC Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm phase 1, dose escalation study of EOC317 in patients with advanced solid tumors.

Detailed description

This is an open-label, single-arm, phase 1, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic effect of EOC317 in patients with advanced solid tumors. The study comprises a dose-escalation phase and a dose-expansion phase. 1. Dose-escalation: using 3+3 design to evaluate the safety, tolerability, and pharmacokinetic profile of EOC317 at 5, 10, 20, 30, 45, 60 mg in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and recommended dose (RDE) for the dose expansion phase. 2. Dose-expansion: based on PK profile in the dose escalation phase, the dose-expansion study will evaluate the safety, tolerability, and preliminary pharmacodynamic effect of the RDE for EOC317 in patients with advanced solid tumors.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	EOC317	tablet(s) PO

Timeline

• Start date: 2018-05-29
• Primary completion: 2020-02-29
• Completion: 2020-11-29
• First posted: 2018-07-11
• Last updated: 2019-09-11

Locations

1 site across 1 country: China