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Theliatinib

Phase 1

Cancer | Small molecule | Oncology |HUTCHMED (China) Limited|Trials Updated: Feb 13, 2020

Theliatinib development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Nov 2015

Theliatinib target and mechanism

Molecular targetEGFR
Target classInhibitor
ModalitySmall molecule

Also known as HMPL-309

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Theliatinib clinical trials

Theliatinib · 1 trial · 1 indication

Phase 1 1
NCT02601248Study of Theliatinib (HMPL-309) in Patients With Advanced Solid TumorCancer
COMPLETED24 Analytics
PHASE1COMPLETED
Study of Theliatinib (HMPL-309) in Patients With Advanced Solid Tumor
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety :the incidence of all adverse events by type and grade, abnormal laboratory changes
from day 1 of first dosing to 30days after permanent discontinuation of Thialitinib

for each patient, adverse events are collected from the date of consent until 30 days after trial discontinuation

Secondary Endpoints

Area under the plasma concentration versus time curve (AUC)
Day 1-3 Single Dose and Day 1-28 Steady State
Peak Plasma Concentration (Cmax)
Day 1-3 Single Dose and Day 1-28 Steady State
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TheliatinibEXPERIMENTALTheliatinib 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 .

Interventions

NameTypeDescription
TheliatinibDRUGTheliatinib is a tablet in the form of 25 mg ,10mg and 100 mg,oral,once daily
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Histopathology confirmed solid tumors * Failed to standard treatment or no standard treatments for uncontrolled, recurrent and/or metastatic advance tumor (whatever previous surgery conditions) * Age 18-75 * Performance status of 0, or 1, and no worse within 7days * Life expec...

Countries:China
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Competitive Landscape -Cancer 7 trials

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Frequently asked questions about Theliatinib

What is theliatinib used for?

Theliatinib is an investigational small molecule being studied for the treatment of cancer. It has been evaluated in patients with advanced solid tumors. It is not approved for any indication and remains in clinical development.

What does theliatinib target?

Theliatinib targets EGFR, the epidermal growth factor receptor. It is an EGFR inhibitor, meaning it is designed to block signaling through this receptor. EGFR is a commonly targeted pathway in oncology drug development.

Who is developing theliatinib?

Theliatinib is being developed by HUTCHMED (China) Limited, which trades under the ticker HCM. The company is the sponsor of the clinical program evaluating the drug in advanced solid tumors.

What phase is theliatinib in?

Theliatinib is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The Phase 1 program has been completed.

What clinical trials is theliatinib in?

Theliatinib has been studied in one clinical trial, NCT02601248, titled Study of Theliatinib (HMPL-309) in Patients With Advanced Solid Tumor. The Phase 1 trial enrolled 24 patients in China and is completed.

Is theliatinib the same as HMPL-309?

Yes, theliatinib is also known as HMPL-309. The two names refer to the same investigational EGFR inhibitor developed by HUTCHMED. The clinical trial listing for the drug uses both names.