Clinical Trials Directory

Trials / Unknown

UnknownNCT05641259

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

Status
Unknown
Phase
Phase 1
Study type
Interventional
Enrollment
198 (estimated)
Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGLP-108Oral administration for 21 or 28 days on a 28-day cycle
DRUGAzacitidineSubcutaneous administration for 7 days on a 28-day cycle at the dose of 75mg/m2 2-2.5h hours after LP-108.

Timeline

Start date
2023-02-14
Primary completion
2024-12-31
Completion
2025-12-31
First posted
2022-12-07
Last updated
2024-02-02

Locations

3 sites across 1 country: China

Source: ClinicalTrials.gov record NCT05641259. Inclusion in this directory is not an endorsement.