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

NCT04260022 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2025-11-05

No results posted yet for this study

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.

Conditions

  • Leukemia, Myeloid, Chronic
  • Myeloid Leukemia
  • Chronic Myeloid Leukemia
  • Philadelphia Positive Acute Lymphoblastic Leukemia
  • B Cell Precursor Type Acute Leukemia

Interventions

DRUG

Ascentage Pharma HQP1351 bioavailable inhibitor

HQP1351 taken by mouth every other day

DRUG

Blinatumomab

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).

Sponsors & Collaborators

  • Ascentage Pharma Group Inc.

    lead INDUSTRY

Principal Investigators

  • Yifan Zhai, MD, PhD · Ascentage Pharma Group Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2029-12-27
Completion
2030-03-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT04260022 on ClinicalTrials.gov