RecruitingPhase 1NCT04260022

Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL

A Phase Ib Study of the Pharmacokinetics, Safety and Efficacy of Orally Administered HQP1351 in Subjects With Refractory Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)


Sponsor

Ascentage Pharma Group Inc.

Enrollment

242 participants

Start Date

Jan 9, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have experienced resistance or intolerance to at least one second or later generation TKI.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called HQP1351 (olverembatinib) for people with chronic myeloid leukemia (CML) or a type of acute lymphoblastic leukemia driven by the Philadelphia chromosome, whose cancer has stopped responding to or cannot tolerate other treatments, including those with a hard-to-treat mutation called T315I. **You may be eligible if:** - You have CML in any phase (chronic, accelerated, or blast) or Ph+ ALL - You have tried and failed or cannot tolerate at least two prior TKI (targeted) drugs - If you have a T315I mutation, the number of prior treatments is not restricted **You may NOT be eligible if:** - You have not tried prior TKI therapies (unless you have a T315I mutation with specific exceptions) - You have severe organ problems or other conditions making this treatment unsafe - You are pregnant or not using appropriate contraception Talk to your doctor to see if this trial is right for you.

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

DRUGAscentage Pharma HQP1351 bioavailable inhibitor

HQP1351 taken by mouth every other day

DRUGBlinatumomab

Administered in all patients as a continuous IV infusion at the dosage of 28μg daily (9μg daily for Cycle 1 Day 1 to Day 7).


Locations(9)

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope

Duarte, California, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Augusta Cancer Center

Augusta, Georgia, United States

University of Maryland

Baltimore, Maryland, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT04260022


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