NCT04260022

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

Recruiting now Phase 1 Last updated 5 November 2025

What this trial tests

Phase 1 trial testing Ascentage Pharma HQP1351 bioavailable inhibitor in Leukemia, Myeloid, Chronic in 242 participants. Currently enrolling.

Timeline

9 January 2020

Primary endpoint
27 December 2029

31 March 2030

Quick facts

Lead sponsor	Ascentage Pharma Group Inc.
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	242
Start date	9 January 2020
Primary completion	27 December 2029
Estimated completion	31 March 2030
Sites	9 locations across Canada, United States

Drugs / interventions tested

• Ascentage Pharma HQP1351 bioavailable inhibitor — full drug profile →
• Blinatumomab (blinatumomab) — full drug profile →

Conditions studied

• Leukemia, Myeloid, Chronic — all drugs for Leukemia, Myeloid, Chronic →
• Myeloid Leukemia — all drugs for Myeloid Leukemia →
• Chronic Myeloid Leukemia — all drugs for Chronic Myeloid Leukemia →
• Philadelphia Positive Acute Lymphoblastic Leukemia — all drugs for Philadelphia Positive Acute Lymphoblastic Leukemia →

Sponsor

Ascentage Pharma Group Inc. — full company profile →

Who can join

18 and older, any sex, with Leukemia, Myeloid, Chronic or Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Resistance to Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia-From Molecular Mechanisms to Clinical Relevance.
   Alves R, Gonçalves AC, Rutella S, Almeida AM, et al · · 2021 · cited 112× · PMID 34638304 · DOI 10.3390/cancers13194820
2. Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label, multicenter phase 1/2 trial.
   Jiang Q, Li Z, Qin Y, Li W, et al · · 2022 · cited 78× · PMID 35982483 · DOI 10.1186/s13045-022-01334-z
3. Treatment of blast phase chronic myeloid leukaemia: A rare and challenging entity.
   Copland M. · · 2022 · cited 31× · PMID 35866251 · DOI 10.1111/bjh.18370
4. Olverembatinib After Failure of Tyrosine Kinase Inhibitors, Including Ponatinib or Asciminib: A Phase 1b Randomized Clinical Trial.
   Jabbour E, Oehler VG, Koller PB, Jamy O, et al · · 2025 · cited 27× · PMID 39570620 · DOI 10.1001/jamaoncol.2024.5157
5. Treatment of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia in Adults.
   Saleh K, Fernandez A, Pasquier F. · · 2022 · cited 24× · PMID 35406576 · DOI 10.3390/cancers14071805
6. FLT3 inhibition by olverembatinib (HQP1351) downregulates MCL-1 and synergizes with BCL-2 inhibitor lisaftoclax (APG-2575) in preclinical models of FLT3-ITD mutant acute myeloid leukemia.
   Fang DD, Zhu H, Tang Q, Wang G, et al · · 2022 · cited 19× · PMID 34710737 · DOI 10.1016/j.tranon.2021.101244
7. Ponatinib-review of historical development, current status, and future research.
   Kantarjian HM, Chifotides HT, Haddad FG, Short NJ, et al · · 2024 · cited 17× · PMID 38727135 · DOI 10.1002/ajh.27355
8. Overcoming Resistance to Kinase Inhibitors: The Paradigm of Chronic Myeloid Leukemia.
   De Santis S, Monaldi C, Mancini M, Bruno S, et al · · 2022 · cited 11× · PMID 35115784 · DOI 10.2147/ott.s289306