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First-in Human (FIH) Trial of ETH-155008 in Subjects With B-NHL, CLL/SLL and AML

Leukemia Clinical Trial

Official title:
A Phase 1a/1b Dose Escalation and Dose Expansion, First-in-human, Open-Labeled Study of ETH-155008 in Subjects With Relapsed or Refractory B-cell NHL, CLL/SLL and AML

Clinical Trial Summary

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

Clinical Trial 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 PK and PD of ETH-155008 and preliminary clinical anti-tumor activity of ETH-155008 in subjects with R/R B-cell Non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia/ Small lymphocytic lymphoma (CLL/SLL) and acute myeloid leukemia (AML). This Trial is a FIH, open-label, multicenter trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ETH-155008 in subjects with R/R B-cell NHL, CLL/SLL and AML 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 6 dose levels ranging from 10 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. Addition 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04840784
Study type Interventional
Source Shengke Pharmaceuticals (Jiangsu) Limited, China
Contact
Status Terminated
Phase Phase 1
Start date June 29, 2021
Completion date May 2, 2023
View Details
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