NCT06423911: POLARIS-2

This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia

Recruiting now Phase 3 Last updated 29 May 2025

What this trial tests

Phase 3 trial testing olverembatinib in Chronic Myeloid Leukemia in 285 participants. Currently enrolling.

Timeline

5 February 2024

Primary endpoint
1 December 2025

1 February 2026

Quick facts

Lead sponsor	Ascentage Pharma Group Inc.
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	285
Start date	5 February 2024
Primary completion	1 December 2025
Estimated completion	1 February 2026
Sites	1 location across United States

Drugs / interventions tested

• olverembatinib — full drug profile →
• Bosutinib (bosutinib) — full drug profile →

Conditions studied

• Chronic Myeloid Leukemia — all drugs for Chronic Myeloid Leukemia →
• CML — all drugs for CML →
• CML, Chronic Phase — all drugs for CML, Chronic Phase →

Sponsor

Ascentage Pharma Group Inc. — full company profile →

Who can join

Adults 18 to 99, any sex, with Chronic Myeloid Leukemia or CML. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• MMR rate Part A
  Time frame: 24 weeks
  To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib
• MMR rate Part B
  Time frame: 24 weeks
  To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation

Sponsor's own description

A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)

Publications & conference data

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

1. 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
2. Angiogenesis and targeted therapy in the tumour microenvironment: From basic to clinical practice.
   Yang S, Fang Y, Ma Y, Wang F, et al · · 2025 · cited 22× · PMID 40268524 · DOI 10.1002/ctm2.70313
3. Focal adhesion in the tumour metastasis: from molecular mechanisms to therapeutic targets.
   Liu Z, Zhang X, Ben T, Li M, et al · · 2025 · cited 12× · PMID 40045379 · DOI 10.1186/s40364-025-00745-7
4. Olverembatinib in chronic myeloid leukemia-Review of historical development, current status, and future research.
   Kantarjian H, Zhai Y, Oehler VG, Jamy O, et al · · 2025 · cited 8× · PMID 40197896 · DOI 10.1002/cncr.35832
5. Treatment-Free Remission in Chronic Myeloid Leukemia: Revisiting the "W" Questions.
   Bruzzese A, Vigna E, Martino EA, Amodio N, et al · · 2025 · cited 2× · PMID 40550748 · DOI 10.1111/ejh.70000
6. Olverembatinib (HQP1351): a third-generation tyrosine kinase inhibitor in the treatment of hematologic and solid malignancies-a comprehensive review of clinical outcomes.
   Sadati S, Yazdizadeh S, Razavi SM, Homayoonfal M, et al · · 2026 · PMID 41547674 · DOI 10.1007/s12672-026-04438-x
7. Efficacy and safety of the third-generation tyrosine kinase inhibitor Olverembatinib in relapsed and persistent minimal residual disease positive Philadelphia chromosome-positive acute lymphoblastic leukemia patients.
   Jiang X, Zhou M, Ma J, Ji Q, et al · · 2025 · PMID 41114036 · DOI 10.3389/fmed.2025.1662512