A Phase I, open-label, multicenter dose-escalation study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of hmpl-309 in patients with advanced solid tumors
There are two stages to this study: a dose-escalation stage and a dose-expansion stage. Dose-escalation stage: hmpl-309 administered orally once every day(QD) to patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. Dose-expansion stage: hmpl-309 administered orally 300mg once every day(QD) to patients which is only for patients with EGFR positive oesophageal carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Theliatinib is a tablet in the form of 25 mg ,10mg and 100 mg,oral,once daily
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Sun-Yat-sen univercity cancer centre
Guangzhou, Guangdong, China
incidence of all types/grades of adverse events
for each patient, adverse events are collected from the date of consent until 30 days after trial discontinuation
Time frame: from first patient in till 30 days after the last patient last visit
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