NCT02601248

Study of Theliatinib (HMPL-309) in Patients With Advanced Solid Tumor

Single Site, Open-label, Dose Escalation Phase I Study of Theliatinib (HMPL-309) in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

First-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), safety and tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of Theliatinib .

Detailed description

Theliatinib (HMPL-309) is a new constructive, high effective, high selective, EGFR tyrosine kinase inhibitor. Theliatinib has demonstrated strong inhibitory effects on multiple tumors with overexpressed EGFR or sensitive EGFR mutations. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), safety and tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of Theliatinib .

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Theliatinib	Theliatinib is a tablet in the form of 25 mg ,10mg and 100 mg,oral,once daily

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-02-01
• Completion: 2016-05-01
• First posted: 2015-11-10
• Last updated: 2020-02-13

Locations

1 site across 1 country: China