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Clinical Trial Summary

This is a Phase 1, open-label, multicenter, dose-escalation & expansion study to evaluate the safety,tolerability and pharmacokinetics (PK) of LP-108, a BCL-2 inhibitor, combined with azacitidine, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RP2D), and to assess the preliminary efficacy of this combination.


Clinical Trial Description

This Phase 1 study will look at different doses and different treatment schedules in order to better understand the effects of the combined regimens on the newly diagnosed or refractory/relapsed adult participants with AML ,MDS or CMML. The procedures include screening for eligibility, study treatments, and blood & bone marrow tests. All the safety events will be record, pharmacokinetic parameters (Tmax, Cmax,T1/2, AUC et al.) will be calculated, response and survival will be assess during the study. Participants will be treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05641259
Study type Interventional
Source Guangzhou Lupeng Pharmaceutical Company LTD.
Contact Yue Shen, PhD
Phone 86-020-31605119
Email yshen@lupengbio.com
Status Recruiting
Phase Phase 1
Start date February 14, 2023
Completion date December 31, 2025

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