RecruitingPhase 1NCT05641259

A Study to Assess Safety and Preliminary Efficacy of LP-108 Combined With Azacitidine In Subjects With AML, MDS, CMML

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LP-108, a BCL-2 Inhibitor, Combined With Azacitidine In Subjects With AML, MDS, CMML


Sponsor

Guangzhou Lupeng Pharmaceutical Company LTD.

Enrollment

198 participants

Start Date

Feb 14, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Azacitidine and a drug called LP-108 for people with acute myeloid leukemia, chronic myelomonocytic leukemia, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

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

DRUGLP-108

Oral administration for 21 or 28 days on a 28-day cycle

DRUGAzacitidine

Subcutaneous administration for 7 days on a 28-day cycle at the dose of 75mg/m2 2-2.5h hours after LP-108.


Locations(3)

The First Affiliated Hospital of Nanchang University

Nanchang, China

First Affiliated Hospital of Soochow University

Suzhou, China

Affiliated Tumor Hospital of Zhengzhou University, Henan Cancer Hospital

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT05641259


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