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Epitinib

Phase 1

Solid Tumor | Small molecule | Oncology |HUTCHMED (China) Limited|Trials Updated: Feb 17, 2020

Epitinib development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2015

Epitinib target and mechanism

Molecular targetEGFR
Target classInhibitor
ModalitySmall molecule

Also known as HMPL-813

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

Epitinib clinical trials

Epitinib · 1 trial · 1 indication

Phase 1 1
NCT02590952A Phase I Study of Epitinib(HMPL-813) in Patients With Advanced Solid TumorsSolid Tumor
COMPLETED108 Analytics
PHASE1COMPLETED
A Phase I Study of Epitinib(HMPL-813) in Patients With Advanced Solid Tumors
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

incidence of all types/grades of adverse events
from first patient in till 30 days after the last patient last visit. It is estimated that last patient last visit happens in Oct 2016.

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

Secondary Endpoints

Objective Response Rate
An average of one year
Area under the plasma concentration versus time curve (AUC)
At single-dose stage (day 1-day 7): predose, 0.5,1, 2, 3, 4, 5, 6, 8,12,24, 36, 48, 72, 144 hours post-dose.
Peak Plasma Concentration (Cmax)
At single-dose stage (day 1-day 7): predose, 0.5,1, 2, 3, 4, 5, 6, 8,12,24, 36, 48, 72, 144 hours post-dose.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EpitinibEXPERIMENTALEpitinib is a capsule in the form of 5mg,20 mg, and 40 mg. Route: oral (daily)

Interventions

NameTypeDescription
EpitinibDRUGThe starting daily dose is 20 mg. Dose escalation will follow daily dose of 40 mg,80 mg, 120 mg, 160 mg, 200 mg, and 250 mg. A 3+3 design applies to this study. Patients will continue taking Epitinib until they experience intolerable adverse events or their diseases are confirmed to be progressed.
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Eligibility Criteria

Age Range18 Years to 70 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 18-70 * ECOG 0-2, and no worse within 7days * Life expected \> 12 weeks * wri...

Countries:China
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumor")

Frequently asked questions about Epitinib

What is Epitinib used for?

Epitinib is an investigational small molecule being studied for the treatment of advanced solid tumors. It is being developed by HUTCHMED (China) Limited and has been evaluated in a Phase 1 clinical trial in patients with solid tumors. It is not yet approved for any indication.

What does Epitinib target?

Epitinib targets EGFR, the epidermal growth factor receptor. It is an EGFR inhibitor, meaning it is designed to block signaling through this receptor. The Phase 1 study of Epitinib was biomarker-selected, enrolling patients based on relevant molecular characteristics.

Who is developing Epitinib?

Epitinib is being developed by HUTCHMED (China) Limited, which trades under the ticker HCM. The company conducted the Phase 1 trial of Epitinib in China.

What phase is Epitinib in?

Epitinib is in Phase 1 clinical development. It has completed one Phase 1 trial in patients with advanced solid tumors. Epitinib is investigational and has not been approved by the FDA or any regulatory authority for commercial use.

What clinical trials is Epitinib in?

Epitinib has been studied in one Phase 1 clinical trial, NCT02590952, titled "A Phase I Study of Epitinib (HMPL-813) in Patients With Advanced Solid Tumors." The trial enrolled 108 patients in China and is now completed. It was an uncontrolled, non-randomized study.

Is Epitinib the same as HMPL-813?

Yes, Epitinib is also known as HMPL-813. The Phase 1 trial of the drug is listed under both names, Epitinib (HMPL-813), so searches for either name refer to the same EGFR inhibitor developed by HUTCHMED.