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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Ascentage Pharma Group Inc.
Study ID
NCT04260022
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ascentage Pharma HQP1351 bioavailable inhibitor — DRUG
    HQP1351 taken by mouth every other day
  • Blinatumomab — DRUG
    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).

Study Details

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.

Key Dates

Start date
Jan 9, 2020
Status verified
Nov 2025
Primary completion
Dec 27, 2029
Completion
Mar 31, 2030

Study Design

Enrollment
242 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
  • Experimental: Cohort B
  • Experimental: Cohort C
  • Experimental: Cohort D

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of HQP1351 [ Time Frame: 28 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Sarah Weaver
[email protected]
205-975-8080
Omer Jamy, MD (PRINCIPAL_INVESTIGATOR)
City of HopeDuarteCalifornia91010
Paul Koller, MD (PRINCIPAL_INVESTIGATOR)
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322
Shannon Gleason
[email protected]
404-778-4334
Anthony Hunter, MD (PRINCIPAL_INVESTIGATOR)
Augusta Cancer CenterAugustaGeorgia30912
Amanda Spires
[email protected]
706-721-8991
Jorge Cortes, MD (PRINCIPAL_INVESTIGATOR)
University of MarylandBaltimoreMaryland21201
Amelia Barkman
[email protected]
Maria Baer, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Erik Lewerenz
[email protected]
216-442-2524
Sudipto Mukherjee, MD (PRINCIPAL_INVESTIGATOR)
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Jovitta Jacob
[email protected]
713-745-6834
Elias Jabbour, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer Research CenterSeattleWashington98109
Kaysey Orlowski
[email protected]
206-667-1997
Vivian Oehler, MD (PRINCIPAL_INVESTIGATOR)

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