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Epitinib

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

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 Tumor
NCT02590952108
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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 9 trials (matched to "Solid Tumor")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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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 currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients with solid tumors, with a focus on biomarker-selected populations.

What does Epitinib target?

Epitinib is a small molecule designed to target specific molecular pathways involved in tumor growth. While the exact molecular target is not publicly detailed, the clinical trial for Epitinib is biomarker-selected, meaning patients are chosen based on the presence of specific genetic or molecular markers that may predict response to the drug.

Who makes Epitinib?

Epitinib is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker symbol HCM. The company is conducting clinical research on Epitinib for the treatment of advanced solid tumors.

What phase is Epitinib in?

Epitinib is currently in Phase 1 clinical development. A Phase 1 study of Epitinib in patients with advanced solid tumors has been completed. The drug is still investigational and has not received regulatory approval for any indication.

What clinical trials is Epitinib in?

Epitinib has one completed clinical trial registered as NCT02590952, titled 'A Phase I Study of Epitinib(HMPL-813) in Patients With Advanced Solid Tumors.' This trial enrolled 108 participants in China and was an uncontrolled, open-label study. The trial is now completed.

Is Epitinib the same as HMPL-813?

Yes, Epitinib is also known as HMPL-813. The clinical trial NCT02590952 refers to the drug as Epitinib (HMPL-813), indicating that these names are used interchangeably for the same investigational compound.