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

NCT05641259 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2024-02-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

LP-108

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

DRUG

Azacitidine

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

Sponsors & Collaborators

  • Guangzhou Lupeng Pharmaceutical Company LTD.

    lead INDUSTRY

Principal Investigators

  • Depei Wu, PhD · First Affiliated Hospital of Soochow University

  • Xudong Wei, PhD · Affiliated Tumor Hospital of Zhengzhou University, Henan Cancer Hospital

  • Qiubai Li, PhD · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  • Li Wang, PhD · First Affiliated Hospital of Chongqing Medical University

  • Fei Li, PhD · The First Affiliated Hospital of Nanchang University

  • Xiaojing Yan, PhD · First Hospital of China Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-14
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05641259 on ClinicalTrials.gov