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OncoMatch/Clinical Trials/NCT06423911

Study of Olverembatinib (HQP1351) in Patients With CP-CML

Is NCT06423911 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including olverembatinib and Bosutinib for chronic myeloid leukemia.

Phase 3RecruitingAscentage Pharma Group Inc.NCT06423911Data as of Jun 2026

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

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Extracted eligibility criteria

Treatments studied

Targeted therapy

olverembatinibBosutinib

Cancer type

Chronic Myeloid Leukemia

Biomarker criteria

Required: BCR::ABL1 T315I mutation

Part B: T315I mutation at screening.

Excluded: BCR::ABL1 T315I mutation

For Part A only: T315I mutation at any time prior to starting study treatment.

Disease stage

Required: Stage CHRONIC PHASE

Diagnosis of CML-CP

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 99

Prior therapy

Min 2 prior lines

Must have received: BCR-ABL inhibitor

Previously treated with at least two approved TKIs

Cannot have received: BCR-ABL inhibitor (olverembatinib)

Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients.

Cannot have received: BCR-ABL inhibitor (bosutinib)

Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients.

Lab requirements

Blood counts

adequate organ functions

Kidney function

adequate organ functions

Liver function

adequate organ functions

Patients with adequate organ functions

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • MD Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06423911 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior BCR-ABL inhibitor, BCR-ABL inhibitor disqualifies patients from enrollment.

Does this trial require BCR::ABL1?

Yes, BCR::ABL1 T315I mutation is a required biomarker for enrollment.

Are patients with BCR::ABL1 alterations eligible?

No. BCR::ABL1 T315I mutation is an exclusion criterion.

What disease stage is eligible?

Stage CHRONIC PHASE is required.

Is there an age limit?

Yes. Patients must be 99 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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