A Phase 1 interventional study of Theliatinib in Cancer, sponsored by Hutchison Medipharma Limited. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-13.
Sponsored by Hutchison Medipharma Limited · Phase 1, Interventional, and Treatment
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 .
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 .
Hutchison Medipharma Limited is the lead sponsor of 66 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Theliatinib investigational product once a day (QD) will be orally administrated on a 28-day cycle There are 5 dose cohorts,including120mg/160mg/200mg/220mg/300mg, QD in the dose escalation stage .
Drug: Theliatinib
Theliatinib is a tablet in the form of 25 mg ,10mg and 100 mg,oral,once daily
Also known as: HMPL-309
Safety :the incidence of all adverse events by type and grade, abnormal laboratory changes
for each patient, adverse events are collected from the date of consent until 30 days after trial discontinuation
Time frame: from day 1 of first dosing to 30days after permanent discontinuation of Thialitinib
Area under the plasma concentration versus time curve (AUC)
Based on single-dose PK result, multi-dose stage subjects take HMPL-309 once a day or twice a day, PK samples are collected of a single oral dose of HMPL-309 on Day 1 to Day 3. At multiple-dose, Pharmacokinetics(PK) sampling will include a pre-dose and at the 0.5,2,4,6,8 hour time points on days 1,15,21of dosing in the first 28-Day cycle of therapy, and pre-dose on days 2,8,16,and 22 of the first 28-Day cycle of therapy
Time frame: Day 1-3 Single Dose and Day 1-28 Steady State
Peak Plasma Concentration (Cmax)
Based on single-dose PK result, multi-dose stage subjects take HMPL-309 once a day or twice a day, PK samples are collected of a single oral dose of HMPL-309 on Day 1 to Day 3. At multiple-dose, Pharmacokinetics(PK) sampling will include a pre-dose and at the 0.5,2,4,6,8 hour time points on days 1,15,21of dosing in the first 28-Day cycle of therapy, and pre-dose on days 2,8,16,and 22 of the first 28-Day cycle of therapy
Time frame: Day 1-3 Single Dose and Day 1-28 Steady State
Plan to share: No
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Hutchison Medipharma Limited