NCT05758610

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shengke Pharmaceuticals (Jiangsu) Limited, China · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objectives of this study are to evaluate the safety of ETH-155008 and to determine the recommended Phase 2 dose (RP2D) regimen or the maximum tolerated dose (MTD). Secondary objectives and endpoints will evaluate the pharmacokinetics(PK) and pharmacodynamics(PD) of ETH-155008 and preliminary clinical anti-tumor activity of ETH-155008 in subjects with R/R acute myeloid leukemia (AML) and Non-Hodgkin's lymphoma (NHL). This Trial is an open-label, multicenter trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ETH-155008 in subjects with R/R AML and NHL who previously received standard treatment or are ineligible for standard treatment options. The study will be conducted in 2 parts: dose escalation (Part 1) and cohort expansion (Part 2). In the dose escalation, ETH-155008 will be administrated orally, once daily (QD) for 28 days at 5 dose levels ranging from 20 mg to 100 mg in 28-day cycles. Dose-limiting toxicity (DLT) will be assessed during the first treatment cycle and the maximum tolerated dose (MTD) will be identified. Additional subjects will be treated in the dose expansion at the commended phase 2 dose (RP2D). During the study, safety will be monitored by the data review committee (DRC) at each dose escalation step and at regular intervals during cohort expansion. Continuous reassessment for DLTs will help minimize the potential risks associated with the study drug. Cumulative data from subsequent treatment cycles will also be monitored for late-onset toxicities.

Conditions

• NHL, Adult
• AML, Adult Recurrent

Interventions

Type	Name	Description
DRUG	ETH-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.

Timeline

• Start date: 2022-11-04
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2023-03-07
• Last updated: 2024-05-08

Locations

2 sites across 1 country: China