OncoMatch/Clinical Trials/NCT05367700
A Study of HS-10382 in Patients With Chronic Myeloid Leukemia.
Is NCT05367700 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including HS-10382(Part 1: Dose escalation) and HS-10382(Part 2: Dose expansion) for cml, chronic phase.
Treatment: HS-10382(Part 1: Dose escalation) · HS-10382(Part 2: Dose expansion) — HS-10382 is a small molecular, oral potent, allosteric inhibitor. By binding a myristoyl site of the BCR-ABL1 protein, HS-10382 locks BCR-ABL1 into an inactive conformation. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic(PK) profile of HS-10382 in patients with chronic myeloid leukemia (CML). Anti-CML activity will also be investigated in this study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Myeloid Leukemia
Biomarker criteria
Required: ABL1 fusion
Required: BCR fusion
Disease stage
Required: Stage CHRONIC PHASE, ACCELERATED PHASE
Excluded: Stage BLAST PHASE
CML-CP/AP patients
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BCR-ABL inhibitor
resistant to or intolerant to previous TKIs therapy
Cannot have received: BCR-ABL1 TKI allosteric inhibitor
Previous treatment with a BCR-ABL1 TKI allosteric inhibitor
Lab requirements
Cardiac function
No impaired cardiac function including: QTc > 470 ms, clinically important ECG abnormalities, risk factors for QTc prolongation or arrhythmia, LVEF ≤ 50%, average heart rate <50 bpm, recent MI or CHF (within 6 months), uncontrollable angina.
Impaired cardiac function including any one of the following: Resting corrected QT interval (QTc) > 470 ms... LVEF ≤ 50%... MI or CHF within 6 months... uncontrollable angina.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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