Spots Global Cancer Trial Database for Study of EOC317 in Chinese Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Study of EOC317 in Chinese Patients With Advanced Solid Tumors

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

Study ID: NCT03583125

Conditions

Solid Tumor

Interventions

EOC317

Study Description

Brief 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.