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Theliatinib

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

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
Cancer
NCT0260124824
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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 5 trials

CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520/ GEH200521- Part A
Zimmer Biomet Holdings, Inc.ZBH1 - Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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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 is currently in Phase 1 clinical development, with one completed trial in patients with advanced solid tumors. The drug is being developed by HUTCHMED (China) Limited.

What does Theliatinib target?

Theliatinib is a small molecule designed to target cancer cells. While the specific molecular target has not been disclosed, the drug is being investigated for its potential to treat advanced solid tumors. It is currently in Phase 1 clinical development.

Who makes Theliatinib?

Theliatinib is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM. The drug is currently in Phase 1 clinical development for the treatment of cancer.

What phase is Theliatinib in?

Theliatinib is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 1 trial has been completed, involving 24 patients with advanced solid tumors in China.

What clinical trials is Theliatinib in?

Theliatinib has one completed clinical trial, identified as NCT02601248, titled 'Study of Theliatinib (HMPL-309) in Patients With Advanced Solid Tumor'. This Phase 1 trial enrolled 24 patients with cancer in China and has been completed.

Is Theliatinib the same as HMPL-309?

Yes, Theliatinib is also known as HMPL-309. The clinical trial NCT02601248, which studied the drug in patients with advanced solid tumors, refers to it as Theliatinib (HMPL-309). The drug is being developed by HUTCHMED (China) Limited.