NCT06532058

Phase IIa Study to Assess Safety and Efficacy in the Relapsed/Refractory Acute Myeloid Leukemia

Safety and Efficacy of QHRD107 Capsule Combined With Venclexta and Azacitidine in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia: a Single-arm, Open, Multicenter Phase IIa Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Changzhou Qianhong Bio-pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of QHRD107 capsule combined with Venclexta and azacitidine in the treatment of relapsed/refractory acute myeloid leukemia: a single-arm, open, multicenter Phase IIa study

Detailed description

This study is a single-arm, open, multicenter phase IIa clinical study, which is divided into two stages: the dose-increasing study phase and the dose-expanding exploration phase. The purpose of the dose-escalation phase is to explore the safety and tolerability of QHRD107 capsule（40mgBID,60mgBID and 80mgBID） combined with Venclexta and azacitidine, to evaluate the efficacy of the three-drug combination in subjects with relapsed/refractory acute myeloid leukemia (R/R-AML), and to explore the pharmacokinetic characteristics of the combination. The dose expansion stage aims to further evaluate the safety, efficacy, pharmacodynamics and pharmacokinetics of QHRD107 capsule（60mgBID and 80mgBID）combined with Venclexta and azacitidine on the basis of exploring the safe dose range determined in the dose escalation stage, and determine the recommended dose for subsequent clinical studies

Conditions

• Relapsed/Refractory Acute Myeloid Leukemia (R/R-AML)

Interventions

Type	Name	Description
DRUG	QHRD107 capsule，Venclexta and Azacitidine	QHRD107（orally），Venclexta（orally），Azacitidine（subcutaneous injection）

Timeline

• Start date: 2023-08-10
• Primary completion: 2025-02-10
• Completion: 2025-05-10
• First posted: 2024-08-01
• Last updated: 2024-08-01

Locations

10 sites across 1 country: China