drugset / Trial / NCT02966171

A Dose Escalation Study to Assess the Safety and Tolerability of HMPL-453 in Patients With Advanced Solid Malignancies

NCT02966171

Phase 1 Terminated 14 enrolled Hutchison Medipharma Limited
NaSingle-groupOpen-labelTreatment

Summary

This is a first-time-in-human, phase I, open-label, dose-escalation study of HMPL-453 in patients with advanced or metastatic solid malignancies who have failed or are intolerable to standard therapies or for whom no standard therapies exist. There are preliminary two stages in this study: a dose-escalation stage (stage 1) and a dose-expansion stage (stage 2). We will decide whether to conduct stage 2 or not one month after the last patient included in stage 1.

Timeline

Start
2017-01
Primary completion
2018-08-23
Completion
2018-08-23

Drugs

EvaluationDrugModalityDoseRoute
Subject HMPL-453 Unknown 25 mg Oral
Subject HMPL-453 Unknown 50 mg Oral
Subject HMPL-453 Unknown 100 mg Oral
Subject HMPL-453 Unknown 200 mg Oral
Subject HMPL-453 Unknown 300 mg Oral
Subject HMPL-453 Unknown 400 mg Oral
Subject HMPL-453 Unknown 500 mg Oral

Indications