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ME-143

Phase 1

Solid Tumors | Small molecule | Oncology |Lite Strategy, Inc.|Last Updated: Jun 24, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

ME-143 · 1 trial · 1 indication

Phase 1 1
NCT01401868Phase I Dose Escalation Study of the Safety and Pharmacokinetics of ME-143 Single Agent for Refractory Solid TumorsSolid Tumors
COMPLETED18 Analytics
PHASE1COMPLETED
Phase I Dose Escalation Study of the Safety and Pharmacokinetics of ME-143 Single Agent for Refractory Solid Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose limiting toxicity
within the first 28 day cycle

Patients will be administered ME-143 IV infusions weekly and assessed by physical exam, vital signs, hematology and clinical chemistry, urinalysis and pharmacokinetic sampling.

Secondary Endpoints

Response rate
baseline and a minimum of every 12 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
single armEXPERIMENTALdose escalation

Interventions

NameTypeDescription
ME-143DRUGexperimental drug, dose escalation with 4 dose cohorts of 2.5 mg/kg, 5 mg/kg, 10 mg/kg, 20 mg/kg; Cycle 1 is 3 weekly IV infusions on Days 1, 8 and 15. If either the 10 mg/kg or 20 mg/kg dose levels are not tolerable, a 7.5 mg/kg or a 15 mg/kg dose level will be evaluated. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal. Once the highest tolerated dose has been determined, patients will be enrolled to receive IV infusions 2-days per week. Cycle 1 at the highest dose level is 3 weekly IV infusions on Days 1, 2, 8, 9, 15 and 16. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Provision of informed consent * Male or female ≥18 years of age * Histologic or cytologic confirmed locally advanced or metastatic cancer that has no standard therapeutic alternatives. * ECOG Performance status 0-1 * A minimum life expectancy of 12 weeks * Adequate bone marrow...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about ME-143

What is ME-143 used for?

ME-143 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development, having completed a single trial in patients with refractory solid tumors. The drug is not yet approved and remains under investigation for its safety and pharmacokinetics.

Who makes ME-143?

ME-143 is being developed by Lite Strategy, Inc., a company traded under the ticker LITS. The company is conducting clinical research on this small molecule for oncology indications, specifically solid tumors.

What phase is ME-143 in?

ME-143 is in Phase 1 clinical development. A Phase 1 dose escalation study has been completed, evaluating the safety and pharmacokinetics of ME-143 as a single agent in patients with refractory solid tumors. The drug is investigational and not yet approved.

What clinical trials is ME-143 in?

ME-143 has one completed clinical trial, NCT01401868, titled 'Phase I Dose Escalation Study of the Safety and Pharmacokinetics of ME-143 Single Agent for Refractory Solid Tumors.' This trial enrolled 18 participants in the United States and was an uncontrolled, open-label study.

Is ME-143 an antibody or a small molecule?

ME-143 is a small molecule therapeutic. It is being developed as an oncology treatment for solid tumors and is currently in Phase 1 clinical trials. The completed study evaluated its safety and pharmacokinetics in patients with refractory solid tumors.