RecruitingPhase 1NCT05758610

A Phase I Study of Euthare-155008(ETH-155008) in AML and NHL Patients

A Phase I Clinical Study of Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ETH-155008 Tablets in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Non-Hodgkin's Lymphoma


Sponsor

Shengke Pharmaceuticals (Jiangsu) Limited, China

Enrollment

60 participants

Start Date

Nov 4, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This Trial is an open-label, multicenter trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ETH-155008 in subjects with AML and NHL who previously received standard treatment or are ineligible for standard treatment options.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase (Phase I) safety study of a new experimental drug called ETH-155008 in people with certain blood cancers — specifically acute myeloid leukemia (AML) or non-Hodgkin's lymphoma (NHL) — whose cancer has come back or stopped responding to standard treatments. **You may be eligible if...** - You are 18–79 years old - You have been diagnosed with relapsed or treatment-resistant AML or certain types of NHL (including follicular lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, chronic lymphocytic leukemia, or others) - You have already tried at least 2 prior treatment regimens (requirements vary by cancer type) - Standard treatment options are no longer available or suitable for you **You may NOT be eligible if...** - You have a history of serious heart conditions or severe organ problems - You have active autoimmune disease or uncontrolled infection - You have received stem cell transplant recently or have serious liver/kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGETH-155008

ETH-155008 is an orally bioavailable, potent Pim-3 and CDK4/6 dual kinase inhibitor. Dosage form: 10mg, 20 mg and 40 mg, tablets. ETH-155008 tablets should be taken while fasting, either 1 hour before or 2 hours after a meal.


Locations(2)

Henan Cancer Hospital

Zhengzhou, Henan, China

Hematology Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

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NCT05758610


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